HypnoCore : SleepRate - Sleep Monitoring Solution

February 5, 2012 - SleepRate aims to revolutionize the field of sleep, utilizing web, mobile, and consumer devices, to allow accurate and affordable access to sleep diagnostics solutions for the consumer market.

SleepRate on YouTube- HypnoCore's website -

Merck : Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia

Feb. 6, 2012 - Company Confirms Plans to File NDA for Suvorexant in 2012 -

Merck (NYSE:MRK), known as MSD outside the United States and Canada, provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012.

Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year... Merck's Press Release -

Alfresa Pharma and Mitsubishi Tanabe Pharma : Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment

November 25, 2011 - Alfresa Holdings Corporation (head office: Tokyo, Representative Director & President: Denroku Ishiguro) and Mitsubishi Tanabe Pharma Corporation (head office: Osaka, President & CEO: Michihiro Tsuchiya) announced that Alfresa Pharma Corporation (head office: Osaka, President & CEO: Kenichiro Iwaya), a subsidiary of Alfresa Holdings engaged in manufacture of pharmaceuticals etc., received approval of a partial change in the indications of MODIODAL® Tablets 100 mg (generic name: modafinil), a sleep disorder treatment, that has been jointly developed in Japan by Alfresa Pharma and Mitsubishi Tanabe Pharma.

Since March 2007, MODIODAL® has been jointly marketed by the two companies as a treatment for excessive daytime sleepiness associated with narcolepsy, a sleep disorder characterized by intolerable daytime sleepiness. The new indication, approved for the first time in Japan, is “excessive diurnal sleepiness accompanied with obstructive sleep apnea syndrome (OSAS) under treatment for airway obstruction by continuous positive airway pressure (CPAP) therapy and the like”. The two companies expect MODIODAL® will contribute to improve quality of life of patients whose daily lives would otherwise be disrupted by excessive diurnal sleepiness in OSAS as well as narcolepsy.

MODIODAL® is currently approved in more than 30 countries in the world, and in seven countries, including the US, it is marketed with approval for the new indication... [PDF] Alfresa's Press Release - [PDF] Mitsubishi Tanabe Pharma's Press Release -

EISAI RECEIVES APPROVAL TO MARKET INSOMNIA TREATMENT LUNESTA® IN JAPAN

January 18, 2012 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta® (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.

Lunesta, originally discovered and developed by Sunovion Pharmaceuticals Inc. (“Sunovion”; formerly Sepracor Inc., “Sepracor”; a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.), has been marketed in the United States since April 2005. The agent was approved as the first insomnia treatment not to have restrictions on its length of use, and is widely used by individuals suffering from insomnia. Eisai has been pursuing the development of Lunesta since acquiring the exclusive rights to develop and market it in Japan from Sunovion (at the time known as Sepracor) in July 2007. The company submitted a marketing authorization application to the MHLW in November 2010.

Lunesta is a non-benzodiazepine type GABAA agonist that is believed to enhance GABA activity while exerting hypnotic and sedative effects. Results from clinical studies conducted in Japan and overseas demonstrated that the agent is effective in those patients who have trouble falling asleep or wake up often during the night, two major symptoms of insomnia. A distinctive feature of Lunesta is that patients do not experience clinically problematic issues such as dependency or carry-over effects or develop a tolerance (experience diminished efficacy) with long-term use... Eisai's Press Release -

Pfizer : Positive Results From Phase 3 Trial Of Lyrica (pregabaline) Capsules CV In Restless Legs Syndrome

December 16, 2011 - Top-Line Results Show Lyrica Met All Co-Primary Endpoints -
Pfizer Inc. (NYSE: PFE) announced that a Phase 3 study for Lyrica (pregabalin) in patients with Restless Legs Syndrome (RLS) met each of its three co-primary endpoints, showing significant benefit as compared with placebo and pramipexole. Pfizer will continue to further analyze these top-line results.

The study, A0081186, was a randomized, double-blind, 12-month trial. It enrolled more than 700 patients, who received either a placebo, Lyrica at 300 mg/day, pramipexole at 0.25 mg/day or pramipexole at 0.5 mg/day.

Patients treated with Lyrica experienced a statistically significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale following 12 weeks of treatment. The Lyrica group also demonstrated a statistically significant improvement following 12 weeks of treatment in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale. In addition, Lyrica treatment resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5 mg/day over 12 months.

The results for this study indicate that the most common adverse events in Lyrica-treated patients were dizziness, somnolence, fatigue, headache and nasopharyngitis (inflammation of the nasal cavity and throat). The adverse event profile is consistent with that known for pregabalin.

Restless Legs Syndrome is a neurological condition that is characterized by an unpleasant irresistible urge to move the legs and, in severe cases, other parts of the body. The symptoms have a circadian pattern and occur mostly in the evening and bedtime. It often results in difficulty falling or staying asleep and can result in periodic limb movements while sleeping, causing partial awakenings that disrupt sleep. RLS has profound negative impact on patients’ quality of life... Pfizer's Press Release -

Impax Pharmaceuticals : Phase IIb Trial of IPX159 in Restless Legs Syndrome

Dec. 19, 2011-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale... Impax Pharmaceuticals' Press Release -

Pierre Fabre Médicament : JONCIA® milnacipran treating fibromyalgia in Australia

On November 17 in Australia, Pierre Fabre Médicament obtained marketing authorization for Joncia® milnacipran in the treatment of fibromyalgia.

Australian drug regulation agency the Therapeutic Goods Administration (TGA) has granted Pierre Fabre Médicament marketing authorization for Joncia® milnacipran, a molecule used in the treatment of fibromyalgia. First discovered by Pierre Fabre's research teams, milnacipran has since been developed for this indication in collaboration with Cypress Bioscience (acquired by Royalty Pharma) and Forest Laboratories.

Approval was granted on the basis of three 3-month Phase III clinical trials conducted in the United States and Europe. These studies, involving over 3,000 patients evaluated using a self-assessment questionnaire, revealed that 100 mg and 200 mg doses of milnacipran resulted in a clinically significant reduction in pain, an overall improvement in symptoms, and a significant improvement in fatigue and sleep. In addition Milnacipran was generally well tolerated with most adverse events being recorded as mild to moderate, and the TGA has announced a positive Joncia® milnacipran benefit/risk ratio... Pierre Fabre Médicament's Press Release -