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 -