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 -
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.
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 -
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 -
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 -
