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 -