Takeda, New Drug Application for Ramelteon in Japan for

February 29, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) announced its submission of a New Drug Application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan.
Ramelteon works by selectively targeting two melatonin receptors in the brain, MT₁ and MT₂. These receptors are located in suprachiasmatic nucleus, a body’s ‘master clock’, which regulates circadian (24-hour) rhythms, including the sleep-wake cycle. By acting on these receptors, body’s sleep-wake cycle is regulated and physiological sleep is promoted... Takeda's Press Release -

Alexza, AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status

Feb. 5 , 2008 - Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has initiated a Phase 1 clinical trial with AZ-007 (Staccato(R) zaleplon). AZ-007 is an inhalation product candidate being developed for the treatment of insomnia patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back asleep. This is the first clinical trial of AZ-007 being conducted under an IND filed recently with the U.S. Food and Drug Administration (FDA). Alexza believes the novel, non-invasive nature and possible rapid pharmacokinetic properties resulting from inhaled zaleplon administration via the Staccato system make AZ-007 a viable product candidate for clinical development in insomnia. Alexza also announced today a status update on its clinical pipeline, including confirming the initiation of its first AZ-004 Phase 3 clinical trial by the end of Q1 2008... Alexza's Press Release -

Covidien, Sandman Intro CPAP Device

Feb 11, 2008 - Covidien Ltd. (NYSE: COV, BSX: COV), a leading supplier of continuous positive airway pressure (CPAP) and other sleep therapy devices and accessories, announced the introduction of an all-new CPAP device with a fully-integrated heated humidifier. The product is available throughout the United States and Europe and will be phased into other global markets over the next year.

The Sandman Intro(TM) CPAP device is a convenient device designed for a broad range of patients and provides continuous positive airway pressure and heated humidification. According to Andy Ray, Vice President and General Manager for Covidien's Sleep and Oxygen Division, "The goal in developing this product was to improve the nighttime breathing comfort of patients with obstructive sleep apnea (OSA) - which we know to be an increasingly common and serious condition - and to accomplish this with a device that is as easy to use as it is unobtrusive."... Covidien's Press Release-

NovaDel, New Drug Application for ZolpiMist(TM) Oral Spray to Treat Insomnia Accepted

Jan 23, 2008 - NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for ZolpiMist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia... NovaDel's Press Release-

XenoPort and GlaxoSmithKline, Second Phase 3 Restless Legs Syndrome Trial for XP13512/GSK1838262

Jan 15, 2008 - XenoPort, Inc. (Nasdaq:XNPT) and GlaxoSmithKline (NYSE:GSK) announced positive top-line results from a placebo-controlled Phase 3 clinical trial designed to evaluate the potential of XP13512 (GSK1838262) to maintain efficacy over the course of nine months in patients with moderate-to-severe primary Restless Legs Syndrome, or RLS... XenoPort's Press Release - GlaxoSmithKline 's Press Release-

Intra-Cellular Therapies, Phase 2 clinical study using its drug candidate ITI-722 for sleep maintenance insomnia

DECEMBER 20TH, 2007 -- Intra-Cellular Therapies, Inc. (ITI), announced it has initiated a sleep maintenance insomnia (SMI) Phase 2 clinical study using its drug candidate ITI-722. ITI-722 acts predominantly as a selective 5-HT2A receptor antagonist and represents an important new approach to the treatment of SMI. Because of its novel separation of 5-HT2A and dopamine receptor modulatory activities, ITI believes, ITI-722 can be used not only to treat SMI but it may be highly appropriate for the treatment of sleep disorders that accompany neurodegenerative disorders, including Parkinson’s disease and other psychiatric disorders... Intra-Cellular Therapies' Press Release -

Actelion, Phase III program RESTORA (REstore physiological Sleep with The Orexin Receptor Antagonist Almorexant)

20 December 2007 – Actelion Ltd (SWX: ATLN) announced that the company has initiated the comprehensive Phase III program RESTORA (REstore physiological Sleep with The Orexin Receptor Antagonist Almorexant) with its first-in-class orexin receptor antagonist, almorexant...RESTORA 1 is expected to confirm the effects of almorexant on sleep induction and sleep maintenance that were previously observed. This study is also expected to provide additional information on sleep architecture and sleep quality, thereby providing further insight into the role of almorexant in restoring normal physiological sleep... Actelion's Press Release -