Covidien : Latest Advance In "Unite to Treat Sleep Apnea" Initiative

10/21/08 - Covidien (NYSE: COV, BSX: COV), a leading global healthcare products company, announced the launch of Sandman Alliance(SM), a first-of-its-kind sleep therapy management program. The Sandman Alliance program is the latest addition to Covidien's "Unite to Treat Sleep Apnea" initiative to improve the diagnosis and treatment of sleep disorders.

The Sandman Alliance program unites patients, sleep clinicians and home care providers in their efforts to treat obstructive sleep apnea (OSA) and other sleep disorders. The patient compliance program provides education, support and encouragement to OSA patients to enhance treatment compliance through personal coaching and empowerment. The program links a sleep counselor with each patient to document progress and track the patient's therapy using a web interface, which provides a common area for the patient's sleep physician to log in and monitor the patient's performance under the program. To support this offering and facilitate its delivery, Covidien has partnered with Assist Management, Inc.

Globally, less than 50 percent of OSA patients recommended for continuous positive airway pressure treatment continue their therapy beyond the first week, and up to 25 percent of remaining patients can be expected to discontinue CPAP use within three years... Covidien's Press Release -

Transcept Pharmaceuticals : Clinical Study of Intermezzo® for the Treatment of Middle-of-the-Night Awakening Published in SLEEP

Oct. 22, 2008 - Phase 3 sleep-lab study demonstrated that low dose sublingual Intermezzo^®, used at the time of a middle of the night awakening, significantly shortened time to return to sleep vs. placebo - Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced that a Phase 3 study evaluating the safety and efficacy of its lead product candidate, Intermezzo® (zolpidem tartrate sublingual lozenge), has been published in the September 2008 issue of SLEEP, a publication of the Associated Professional Sleep Societies. Intermezzo® is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid to be indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep... Transcept Pharmaceuticals' Press Release -

Forest Laboratories and Cypress Bioscience : FDA Defers Final Action on milnacipran New Drug Application

Oct 20, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) (the "Companies") announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not able to take final action by the scheduled Prescription Drug User Fee Act action date of October 18, 2008, on their New Drug Application for milnacipran, a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia.

The FDA has not requested any additional information from the Companies but did indicate that a clinical data question related to the NDA submission required confirmation. The FDA indicated that their assessment could be completed in a matter of weeks, but could not confirm specific timing. The FDA could not provide further information as to the reason for the delay. The Companies continue to plan for a first quarter 2009 product launch meeting... Forest Laboratories' Press Release - [PDF] Cypress Bioscience's Press Release -

Omeros and The Parkinson's Institute : Collaboration Agreement to Evaluate Novel Target for the Treatment of Movement Disorders

September 17, 2008 – Omeros Corporation and The Parkinson’s Institute and Clinical Center announced that they have entered into a collaboration to evaluate a novel target, proprietary to Omeros, for the treatment of movement disorders. The collaboration is based on Omeros’ discovery and prior validation of a previously unknown link between this molecular target in the brain and movement disorders such as Parkinson’s disease and Restless Legs Syndrome (RLS)... [PDF] Omeros' Press Release -

Neurogen : Positive Results for Aplindore in Restless Legs Syndrome and Parkinson's Disease

Oct. 14, 2008 - Neurogen Corporation (Nasdaq: NRGN) announced positive top-line results from two Phase 2 clinical trials in restless legs syndrome (RLS) and Parkinson's disease with the Company's dopamine partial agonist, aplindore. These studies were the first in which aplindore has been evaluated in RLS and Parkinson's disease.

In each study, aplindore demonstrated highly significant efficacy and was well tolerated. Neurogen believes aplindore's dopamine partial agonist controlled release profile may be better tolerated, with fewer side effects and greater dosing flexibility, than existing drugs to treat RLS and Parkinson's disease. Side effects of RLS drugs currently on the market or in late-stage development include daytime somnolence, dizziness and nausea. These drugs require titration, or slow escalation of doses, over several days or weeks to achieve an effective dose. Side effects of drugs currently available for the treatment of Parkinson's disease include nausea, somnolence, hallucinations and dyskinesias, or involuntary movements, and also require titration to reach therapeutic doses... Neurogen' Press Release -

Covidien Partners with Sleep Pointe to Bring Sleep Apnea Education, Diagnosis and Treatment to Transportation Industry

Jun 19, 2008 - Covidien (NYSE: COV, BSX: COV), a leading global healthcare products company, announced the latest advance in its "Unite to Treat Sleep Apnea" initiative, an integrated program connecting physicians, sleep labs, treatment providers and patients to improve the diagnosis and treatment of those afflicted with obstructive sleep apnea. The Company is now partnering with Sleep Pointe, an organization dedicated to providing sleep apnea management and wellness programs within the transportation industry.


Covidien created the "Unite to Treat Sleep Apnea" initiative in response to the increased demand for sleep apnea treatment. According to the National Institutes of Health, approximately 12 million Americans suffer from sleep apnea, and an additional 10 million remain undiagnosed... Sleep Pointe's Press Release -

Apnea Sufferers Can Aid Their Health With InnoMed/RespCare CPAP Masks

Sep 09, 2008 - ...InnoMed Technologies represents the Nasal-Aire(R) family CPAP interfaces and RespCare, Inc. represents such innovative CPAP technologies as the Hybrid Universal Oral/Nasal Pillow interface and the Bravo Nasal pillow Interface.
The two studies, one of which was sponsored by National Institutes of Health's National Center on Sleep Disorders Research, demonstrated an increased risk of death among apparently healthy people who suffered from moderate to severe apnea. Studies found that sleep apnea, characterized by disruptions of breathing during the night, increases the risk of death four- to six fold. The condition affects as many as 12 million Americans.
In the past, studies have linked an increased risk of death with people who suffered from apnea and other health-related problems, such as obesity...
...InnoMed Technologies' range of technologically advanced Nasal-Aire(R) interfaces for positive air pressure therapy has helped patients who could not deal with a face mask become and stay compliant. The Nasal-Aire (R) II , which wears like an oxygen cannula, has remained the Gold Standard in alternative interfaces since it was introduced in 2002.
The Hybrid (R) Universal Interface offers patients the comfort of nasal pillows, yet allows the patient to breathe through their mouth during the night without interrupting the nightly therapy. Many sleep centers prefer the Hybrid (R) when trying a patient on CPAP for the first time because most patients with sleep disorders are mouth breathers and cannot comfortably comply to nasal masks...InnoMed Technologies' Press Release -

SleepQuest and ResMed : Latest Sleep Disorder Technology Tested

August 28, 2008 - SleepQuest has partnered with ResMed, a leading manufacturer of medical equipment for sleep-disordered breathing, to conduct clinical trials of a new wireless technology used to monitor patients with Obstructive Sleep Apnea from wherever they are sleeping.
The technology is intended to more easily provide data that can be used to improve the quality of care for those requiring PAP treatment... SleepQuest's Press Release -

Fralex Therapeutics : update on timing of interim analysis results

September 25, 2008 – Fralex Therapeutics Inc. (TSX:FXI) , a medical technology company developing a non-invasive neuromodulation device, provided an update on receiving results of the interim analysis for the RELIEF pivotal study. The trial is investigating the use of Complex Neural Pulse or CNPTM therapy for the relief of chronic pain associated with fibromyalgia.
The Independent Data Monitoring Committee (“DMC”) is scheduled to meet on October 2, 2008, to review data from the first 100 patients enrolled in the trial... [PDF] Fralex Therapeutics's Press Release -

GlaxoSmithKline & XenoPort : submission of new drug application requesting FDA approval of Solzira™ for Restless Legs Syndrome

September 16, 2008 - GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.

Solzira is a non-dopaminergic new chemical entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation... GlaxoSmithKline's Press Release - XenoPort's Press Release -

Sepracor : LUNESTA(R) Next-Day Function and Discontinuation Data from a Long-Term 12-Week Study in Elderly Patients Presented at ECNP

Sept. 3, 2008 - Sepracor Inc. (Nasdaq: SEPR) announced the presentation of LUNESTA(R) brand eszopiclone Phase IV study data at the 21st European College of Neuropsychopharmacology (ECNP) Congress in Barcelona. The poster presentations reflected results from a 12-week, double-blind, randomized safety and efficacy study of 388 elderly patients (65-85 years of age) who were administered either LUNESTA 2 mg or placebo nightly. Upon conclusion of the 12-week, double-blind treatment period, all patients received single-blind placebo for two weeks to assess rebound and withdrawal effects. This two-week, single-blind period was then followed by an additional two-week evaluation period in which patients received neither LUNESTA nor placebo in order to assess the durability of the response.

A 12-Week Study of Eszopiclone in Elderly Out-patients With Primary Insomnia: Effects of Treatment Discontinuation

In this study, sleep latency, wake time after sleep onset and total sleep time were all statistically significantly... Sepracor's Press Release -

Somaxon : Pharmacological Data on Doxepin at the 21st European College of Neuropsychopharmacology Congress

September 02, 2008 - Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, announced that data from a pharmacological profiling study relating to doxepin, the active ingredient in the company’s product candidate Silenor for the treatment of insomnia, were presented yesterday at the 21st European College of Neuropsychopharmacology (ECNP) Congress.

The data presented at the ECNP Congress are from a study that examined the in vitro pharmacological profile of doxepin. The study evaluated the relative affinity and functional activity of doxepin at various central nervous system (CNS) targets known to play a role in its overall pharmacological profile.

The results demonstrate that doxepin has high affinity for and potent antagonistic activity at the human H₁ histamine receptor, which is thought to be a primary mediator of the sleep-wake cycle. In addition, doxepin was shown to have lower or little affinity for a number of other CNS binding sites.

It is hypothesized that at the point in the circadian cycle during which the release of histamine and wakefulness are both naturally reduced, blocking the H₁ receptor can further reduce wakefulness and promote the initiation and maintenance of sleep. The high potency of doxepin as an H₁ antagonist represents the likely mechanism for its sleep-promoting effects and provides a potential explanation for its efficacy in humans at oral doses of 1 mg, 3 mg and 6 mg, the doses evaluated in the company’s clinical trials of Silenor for the treatment of insomnia. In addition, the relative selectivity of doxepin for H₁ as compared to a number of other neuropharmacological sites may account for the low incidence in such clinical trials of adverse events that have been associated with higher doses (25 mg to 50 mg) of doxepin... [PDF] Somaxon's Press Release -

Boehringer Ingelheim : Pramipexole clinical trial programme in Restless Legs Syndrome (RLS) reveals new significant results

26 August 2008 – Results from a large pramipexole trial programme in Restless Legs Syndrome (RLS) conducted by Boehringer Ingelheim were presented at the 12th European Federation of Neurological Societies (EFNS) Annual Congress held in Madrid, Spain, from 23 to 26 August. The results of two large Phase IV trials showed that while pramipexole significantly improves the characteristic symptoms of RLS among patients with moderate to severe RLS, it also demonstrated significant beneficial effects on associated symptoms such as limb pain and health-related quality of life, including associated mood disturbance. Limb pain and mood disturbance are important secondary ailments commonly experienced by RLS patients, and these studies are the first in which an approved RLS treatment has demonstrated benefits addressing these symptoms in a clinical study in RLS patients... Boehringer Ingelheim's Press Release - Boehringer Ingelheim's Press Release -

GlaxoSmithKline and Actelion : exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond

Monday 14 July 2008 - GlaxoSmithKline and Actelion to potentially co-develop and co-commercialise other orexin receptor antagonists - GlaxoSmithKline (GSK) and Actelion Ltd (SWX: ATLN) announced that they have entered into an exclusive worldwide collaboration (excluding Japan) for Actelion’s almorexant, an orexin receptor antagonist in phase III development with first-in-class potential as a treatment for primary insomnia.

Under the terms of the agreement, GSK will receive exclusive worldwide rights to co-develop and co-commercialise almorexant. Actelion will continue to lead the ongoing development programme and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40 per cent of the costs. Almorexant will also be studied in other orexin-related disorders and all costs related to these programmes will be shared equally... GlaxoSmithKline's Press Release - Actelion's Press Release -

SRI International : Research Team Identifies Rare Sleep-Activated Neurons in the Cerebral Cortex

July 21, 2008 - Findings May Have Important Implications for Treatment of Sleep Disorders and for Understanding Mood and Memory – SRI International announced that a research team has identified the first example of neurons that are activated in the cerebral cortex during slow wave sleep (SWS). The research, led by Dmitry Gerashchenko and Thomas Kilduff, will be published in the Proceedings of the National Academy of Sciences (PNAS) in a paper titled Identification of a Population of Sleep-Active Cerebral Cortex Neurons. The paper is available via the PNAS Web site starting July 21.

The presence of slow waves in the electroencephalogram (EEG) is the distinctive “signature” of SWS and a type of activity that does not normally occur during wakefulness. For years, researchers have hypothesized that ‘slow-wave activity’ (SWA) is correlated with the recuperative properties of sleep and the brain’s ability to learn, in part, because brain cells are relatively quiet during this time. While populations of neurons activated during sleep have been identified in the forebrain and the hypothalamus, up until this point, neurons in the cortex have been seen as dormant. These new results show that a group of rare neurons are active, rather than at rest, during SWS... SRI International's Press Release -

Orexo and Meda AB : The FDA has accepted for filing the registration application for Sublinox

July 29, 2008 - The submitted registration application for Sublinox^TM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. Sublinox^TM contains the well-known active substance zolpidem and is based on Orexo´s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.



Meda AB acquired the exclusive world-wide commercialization rights for Sublinox^TM on April 14, 2008...
... The data supporting the product includes a clinical study in insomnia patients that was completed in October 2007... Orexo´s Press Release - [PDF] Meda AB's Press Release -

GE Healthcare : to Acquire Vital Signs, Inc., Expanding GE's Monitoring, Anesthesia and Respiratory Care Offerings

July 24, 2008 – GE Healthcare, a unit of General Electric Company (NYSE: GE), and Vital Signs, Inc. (NASDAQ: VITL) announced that they have entered into a definitive merger agreement for GE to acquire Vital Signs. Under the terms of the agreement, shareholders of Vital Signs will receive $74.50 per share in cash for each Vital Signs share they own.

Vital Signs is a global provider of medical products applicable to a wide range of care areas such as anesthesia, respiratory, sleep therapy and emergency medicine. Vital Signs has a broad product offering of innovative single-patient use products which offer significant cost advantages and improved patient care features, including reducing the potential of transmitting infections from one patient to another.

Vital Signs will become part of GE Healthcare’s Clinical Systems business, a world-class provider of advanced technologies for patient monitoring, anesthesia delivery and acute respiratory care. The strong strategic fit between the two businesses will offer substantial customer benefits through complementary product and service offerings... GE Healthcare's Press Release - Vital Signs' Press Release -

Chelsea Therapeutics : MHRA Approval to Begin Phase II Trial of Droxidopa in Fibromyalgia

July 23, 2008 - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II trial of Droxidopa, alone and in combination with carbidopa, for the treatment of Fibromyalgia.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -

Takeda : to Appeal EMEA Negative Opinion on ramelteon for the Treatment of Primary Insomnia

June 17, 2008 – Takeda Pharmaceutical Company Limited (“Takeda”) announced that its wholly owned subsidiary, Takeda Global Research & Development Centre (Europe) Ltd. (“TGRD(EU)”), has requested a re-examination of the opinion given by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

This request is in response to the negative opinion of May 30, 2008, in which the CHMP recommended the refusal of the marketing authorization in the EU for ramelteon in the treatment of patients with primary insomnia, since the CHMP was concerned that the effectiveness of ramelteon had not been demonstrated, which was measured considering only one aspect of insomnia, the time to fall asleep... Takeda's Press Release -

Neurogen : Suspension of Insomnia Study with Adipiplon

July 13, 2008 - Neurogen Corporation (Nasdaq: NRGN) announced that, as planned, it commenced a Phase 2/3 clinical trial in chronic insomnia patients with the Company's insomnia agent, adipiplon and that, based upon reports from initial dosing of a higher than anticipated rate of unwanted next day effects, the Company has suspended dosing in the study. Neurogen believes that the bilayer tablet formulation of adipiplon being used in the study may not be performing as expected.

The Company plans additional investigation of the bilayer tablet before proceeding further. In prior studies Neurogen has simultaneously administered various doses of both immediate release and controlled release forms of adipiplon. The current study is the first trial in which it has used the two forms laminated together into one bilayer tablet. In previous testing in over 600 subjects, adipiplon has been well tolerated... Neurogen's Press Release -

Actelion and GlaxoSmithKline : exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond

14 July 2008 - Actelion Ltd (SWX: ATLN) and GlaxoSmithKline (LSE and NYSE: GSK) announced that they have entered into an exclusive worldwide collaboration (excluding Japan) for Actelion's almorexant, an orexin receptor antagonist in phase III development with first-in-class potential as a treatment for primary insomnia.

Under the terms of the agreement, GSK will receive exclusive worldwide rights to co-develop and co-commercialise almorexant. Actelion will continue to lead the ongoing development programme and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40 per cent of the costs.
Almorexant will also be studied in other orexin-related disorders and all costs related to these programmes will be shared equally... Actelion's Press Release - GSK's Press Release -

Vanda Pharmaceuticals : Phase III Data Show Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

June 26, 2008 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) (Vanda) announced positive top-line results from a Phase III trial showing that its investigational drug candidate, tasimelteon (VEC-162), a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia.

We are excited that the results of this Phase III chronic insomnia study demonstrate the clinical utility of tasimelteon and the ability of the compound to treat sleep disorders over a period of four weeks. The mechanism of action of tasimelteon as a circadian regulator gives Vanda the opportunity to explore its use for the treatment of circadian rhythm sleep disorders as well as chronic primary insomnia... Vanda Pharmaceuticals' Press Release -

Lilly : FDA Approves Cymbalta for the Management of Fibromyalgia

June 16, 2008 - The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced. Cymbalta is the first serotonin- norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. The fibromyalgia indication represents the second FDA-approved use for Cymbalta for a pain disorder, demonstrating the medication's analgesic effect... Lilly's Press Release -

Transcept Pharmaceuticals : Intent to Submit New Drug Application for Intermezzo in Q3 2008

June 4, 2008 - Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced that it has completed all pivotal and supporting clinical trials that will be included in the new drug application (NDA) for its lead product candidate, Intermezzo^® . Following its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on April 2, 2008, Transcept now expects to submit the Intermezzo^® NDA in the third quarter of 2008. Transcept’s meeting with the FDA was triggered by the Company’s successful completion of a second Phase 3 clinical trial of Intermezzo^® (3.5 mg zolpidem tartrate sublingual lozenge), a low dose buffered sublingual formulation designed to treat insomnia in patients who awaken in the middle-of-the-night (MOTN) and have difficulty returning to sleep... Transcept's Press Release -

Sanofi-aventis : Ambien CR Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder

June 10, 2008 - Sanofi-aventis announced today results from a new study that showed Ambien CR(R) (zolpidem tartrate extended-release) CIV tablets 12.5 mg provided significant improvement in sleep onset, sleep maintenance and total sleep time over 8 weeks in patients with co-morbid insomnia and major depressive disorder (MDD) who were administered a Selective Serotonin Reuptake Inhibitor (SSRI) for depression. Ambien CR also improved sleep-related next-day functioning measures. This data was presented at the SLEEP 2008 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS)... [PDF] Sanofi-aventis' Press Release -

ResMed and LifeScan : Co-Marketing Agreement Focused on Treatment of Type 2 Diabetes and Sleep-Disordered Breathing

June 10, 2008 – LifeScan, Inc., maker of the leading OneTouch® Brand of blood glucose meters for people with diabetes, and ResMed, Inc. (NYSE: RMD), a leading manufacturer of medical devices for the diagnosis and treatment of sleep apnea, today announced an exclusive co-marketing agreement designed to improve the lives of people with type 2 diabetes and sleep-disordered breathing (SDB). The joint work of the two companies will focus on educational and cross-promotional efforts intended to benefit the patients and healthcare professionals served by both companies.

The goal is to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and ultimately improve the rate of treating patients suffering from both SDB and diabetes... LifeScan's Press Release -

Pipex Pharmaceuticals : Oral Flupirtine Receives IND with FDA For Phase II Clinical Trial For Fibromyalgia

April 21, 2008 - Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, today announced that the United States FDA has opened an Investigational New Drug Application (IND) to conduct a double-blind, randomized, placebo-controlled Phase II clinical trial of oral flupirtine for the treatment of fibromyalgia, a rheumatic pain disease which affects an estimated 6 million Americans. Lyrica®, the only FDA-approved medication for the treatment of fibromyalgia amongst other indications, recorded $1.8 billion in sales during 2007, with 47 percent annual growth...
...This phase II clinical trial is designed as a double-blind, placebo controlled phase II clinical trial which would evaluate safety and efficacy of oral flupirtine vs. placebo in fibromyalgia patients. This phase II clinical trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days and the primary endpoint will be a reduction in musculoskeletal pain and the overall symptoms of fibromyalgia. Secondary outcomes of the study will be a reduction in the severity of mood, fatigue, cognitive symptoms, and sleep disturbance, as well as improve the overall level of functioning... Pipex Pharmaceuticals' Press Release -

UCB : Neupro recommended for approval in Europe for Restless Legs Syndrome

25 April, 2008 - UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for Neupro® (rotigotine transdermal patch) in the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults.
The CHMP decision is based on data from two well-controlled clinical trials that evaluated the efficacy and safety of Neupro® over a six month period in almost 1,000 patients with RLS. In these trials, Neupro® showed significant and clinically relevant improvements in RLS symptoms compared to placebo and was generally well tolerated... UCB's Press Release -

Sepracor : LUNESTA Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General Psychiatry

May 12, 2008--Sepracor Inc. (Nasdaq: SEPR) announced the publication of a study of LUNESTA tablets in patients with insomnia and co-morbid generalized anxiety disorder (GAD) in the May issue of the Archives of General Psychiatry. This 595-patient study examined the safety and efficacy of LUNESTA co-administered with escitalopram oxalate, which is commonly used in the treatment of anxiety, versus co-administration of escitalopram and placebo in patients with insomnia and co-existing GAD. The study also evaluated the potential for co-administration of LUNESTA to increase the magnitude and/or accelerate the anxiolytic response versus escitalopram alone... Sepracor's Press Release -

Lundbeck : Circadin launch rollout starts with the launch of the product in the important German market

13-05-2008 - Lundbeck announced the launch of Circadin® for insomnia in Germany. Circadin® was approved by the European Commission on 29 June 2007, and Lundbeck expects to launch the product in another 14 markets during 2008.

"We are very happy to have launched Circadin® in Germany, which is the first of the 15 markets in Europe where Lundbeck expects to roll out Circadin® during 2008...

...Circadin® is the first and only IP-protected, prolonged-release, melatonin-containing prescription drug approved in the EU. Melatonin is a naturally occurring hormone produced by the pineal gland; and it has a pivotal role in the regulation of circadian rhythms and sleep... Lundbeck's Press Release -

SOMAXON PHARMACEUTICALS : CLINICAL DATA ON PRODUCT CANDIDATE FOR THE TREATMENT OF INSOMNIA PRESENTED

May 7, 2008 − Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that data from three Phase 3 clinical trials of the company’s product candidate SILENOR™ (doxepin HCl) for the treatment of insomnia were presented at the American Psychiatric Association (APA) 161st annual meeting in Washington, D.C..
The data presented at the APA meeting are a subset of the data from Somaxon’s completed Phase 3 development program, which comprised four Phase 3 clinical trials evaluating SILENOR™, a low-dose (1-6 mg) formulation of doxepin for the treatment of insomnia. As the company has previously reported, all of these clinical trials demonstrated statistically significant differences relative to placebo for their primary endpoints and multiple secondary endpoints. The clinical trials demonstrated significant and clinically meaningful improvements in sleep onset, sleep maintenance and the prevention of early morning awakenings... [PDF] Somaxon's Press Release -

Medison Pharma : Provigil is approved for Idiopathic Hypersomnia, Sleep Apnea and Shift Work Disorder treatment

May 14, 2008 Medication for Idiopathic Hypersomnia is approved in Israel

The Pharmaceutical Administration has approved Provigil for the treatment of Idiopathic Hypersomnia, Sleep Apnea and Shift Work Disorder

Dr. Itay Gal

Hundreds of Israelis suffer from Idiopathic Hypersomnia manifested by fatigue throughout the day, difficulty in maintaining wakefulness even after a long night sleep or after daytime naps.
Lately, the Israeli Ministry of Health has approved the marketing of Provigil for the purpose of providing solution for Idiopathic Insomnia as well.

This problem usually starts at adolescence. People suffering from Idiopathic Hypersomnia experience significant impairment in their quality of life, as well as difficulty in concentrating in all of their activities due to sleepiness, which is probably the result of dysfunction in their "biological clock"...

...Additional indication for the medication includes treating people suffering from Sleep Apnea Syndrome. The signs of this common syndrome are overweight, snoring, fatigue and sleepiness throughout the day. People suffering from this disorder experience cyclical interruptions during sleep causing short intervals of awakening from sleep without being aware of it. The number of awakenings from sleep can be dozens or even hundreds of times throughout the night...

...People suffering from Sleep Apnea are at increased risk for developing cardiovascular illness as well as being involved in road accidents and work-related accidents due to inadequate alertness. It is estimated that thousands of Israelis suffer from this problem and only few are diagnosed and treated. Treatment involves a multidisciplinary approach including weight loss, CPAP (Continuous Positive Airway Pressure) machines, surgery and dental devices. Despite optimal treatment, some patients still suffer from excessive sleepiness throughout the day requiring medicinal treatment.... Medison Pharma's Press Release -

Eurand : Launch of OTC Unisom SleepMelts by Chattem

April 29, 2008 – Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that Chattem, Inc. (“Chattem”) has launched a new orally disintegrating tablet (“ODT”) formulation of its popular over-the-counter (OTC) sleep-aid brand, Unisom^®.

Unisom^® SleepMelts^TM, which contains 25mg of diphenhydramine hydrochloride, was developed by Eurand using its AdvaTab^® and Microcaps^® taste-masking technologies. The product was developed as part of the EUR-1047 program. Unisom^® SleepMelts^TM, an OTC sleep-aid, is now available in leading U.S. mass merchandiser, drug and food retailers. Eurand will exclusively supply the product for Chattem, which will be manufactured at Eurand’s U.S. facility in Vandalia, OH... – Eurand's Press Release -

Pfizer : Lyrica Reduced Pain of Fibromyalgia in Patients Regardless of Symptoms of Anxiety or Depression

April 16, 2008 - -Pfizer’s Lyrica reduced pain of fibromyalgia in patients regardless of whether they experienced symptoms of anxiety or depression at the beginning of the study, according to a pooled analysis presented today at the American Academy of Neurology annual meeting. The analysis, which looked at data pooled from previous clinical trials, also showed that patients’ self-reported improvements were more closely associated with improvements in pain and sleep than with improvements in fatigue or symptoms of anxiety or depression.

Fibromyalgia is the most common, chronic widespread pain condition in the United States and is thought to result from neurological changes in how patients perceive pain. Fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue... Pfizer's Press Release -

Sanofi-aventis : Positive results from GEMS, the third Phase III trial evaluating eplivanserin in sleep quality

April 30, 20008 - ... Eplivanserin : Sanofi-aventis announced today that the GEMS Phase III study shows that the 5-HT2A antagonist eplivanserin in development for the treatment of insomnia characterized by sleep maintenance difficulties/night- time awakenings significantly reduces WASO (Wake time After Sleep Onset) and the number of night-time awakenings reported by the patient at 6 and 12 weeks of treatment, versus placebo. An improvement of the quality of sleep was also observed in the study.

These results confirm those of the EPLILONG study (phase III study conducted in similar conditions), which also showed that eplivanserin significantly reduces WASO and the number of night-time awakenings reported by the patient at 6 and 12 weeks, versus placebo and improves the quality of sleep... [PDF] Sanofi-aventis' Press Release -

XenoPort and GlaxoSmithKline : XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome

April 17, 2008 - Data from the first pivotal study of XP13512/GSK1838262, a sustained-release investigational compound to treat Restless Legs Syndrome (RLS), showed that it significantly improved the symptoms of moderate-to-severe primary RLS compared to placebo, and was generally well-tolerated when administered once-daily for 12 weeks Data from the PIVOT RLS I (Patient Improvement in Vital Outcomes following Treatment for RLS) clinical trial, formerly designated as study XP052, were presented today at the 60th annual meeting of the American Academy of Neurology (AAN). The investigational compound is being developed by XenoPort (Nasdaq: XNPT) - GSK.

"This novel compound is the first non-dopaminergic agent to demonstrate efficacy in treating the symptoms of RLS in large controlled clinical trials... XenoPort's Press Release -

Transcept Pharmaceuticals : Study of Intermezzo by Leading Sleep Expert Published in "Human Psychopharmacology"

April 15, 2008: Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced today that a study evaluating the pharmacodynamics, pharmacokinetics, and tolerability profile of its lead product candidate,Intermezzo^®, has been published in Human Psychopharmacology. Intermezzo^® (zolpidem tartrate sublingual lozenge) is a low dose formulation of zolpidem designed to treat insomnia in patients who awaken in the middle of the night and have difficulty returning to sleep... Transcept Pharmaceuticals' press Release -

SleepQuest : Medicare Approves In Home Sleep Apnea Testing

April 8, 2008 - The Centers for Medicare and Medicaid Services (CMS) have approved at-home sleep testing for obstructive sleep apnea (OSA). Previous policy had mandated that suspected sleep apnea sufferers undergo facility-based polysomnography. The new policy allows continuous positive airway pressure (CPAP) treatment for Medicare patients who are diagnosed via unattended home monitoring devices. This decision will likely prompt increased coverage from insurance companies around the country.“SleepQuest is very excited about the change in coverage as it demonstrates that our portable sleep testing program, which we have successfully offered for the past 14 years, is a viable and effective alternative to sleep lab testing... SleepQuest's Press Release -

Arena : Phase 2b Clinical Trial of APD125 for the Treatment of Insomnia

April 8, 2008 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it initiated screening in a Phase 2b clinical trial of APD125 in patients with primary insomnia. APD125 is an oral drug candidate discovered by Arena with the potential to reduce insomnia symptoms and improve sleep maintenance and quality.

The Phase 2b trial of APD125 is a double-blind, randomized, placebo- controlled subjective study evaluating the efficacy and tolerability of APD125 in patients with primary insomnia characterized by difficulty maintaining sleep. The trial, which is expected to enroll a total of approximately 675 male and female patients in about 70 clinical sites in the United States, will evaluate two doses (20 mg and 40 mg) and placebo over 14 nights of treatment. The trial will evaluate standard subjective measurements of sleep, including change from baseline in subjective number of awakenings after sleep onset (sNAASO), which is the primary endpoint... Arena Pharmaceuticals' Press Release -

Medtronic : Agreement to Acquire Restore Medical

April 22, 2008 – Medtronic, Inc. (NYSE: MDT) and Restore Medical, Inc. (NASDAQ: REST) announced that the companies have signed a definitive agreement under which Medtronic will pay $1.60 per share in cash for each share of Restore Medical stock. The total value of the transaction, including payment of Restore Medical debt will be approximately $29 million.
The transaction, which is anticipated to close within 90 days, is expected to be accretive to Medtronic earnings in the first full fiscal year after closing. Restore Medical’s Pillar Palatal Implant System (Pillar System) is an innovative, minimally invasive, implantable medical device used to treat the soft palate component of sleep breathing disorders, including mild to moderate obstructive sleep apnea (OSA) and snoring... Medtronic' Press Release -