Fralex Therapeutics : update on timing of interim analysis results

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.
The Independent Data Monitoring Committee (“DMC”) is scheduled to meet on October 2, 2008, to review data from the first 100 patients enrolled in the trial... [PDF] Fralex Therapeutics's Press Release -

GlaxoSmithKline & XenoPort : submission of new drug application requesting FDA approval of Solzira™ for Restless Legs Syndrome

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 -

Sepracor : LUNESTA(R) Next-Day Function and Discontinuation Data from a Long-Term 12-Week Study in Elderly Patients Presented at ECNP

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 -

Somaxon : Pharmacological Data on Doxepin at the 21st European College of Neuropsychopharmacology Congress

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 -

Boehringer Ingelheim : Pramipexole clinical trial programme in Restless Legs Syndrome (RLS) reveals new significant results

26 August 2008 – Results from a large pramipexole trial programme in Restless Legs Syndrome (RLS) conducted by Boehringer Ingelheim were presented at the 12th European Federation of Neurological Societies (EFNS) Annual Congress held in Madrid, Spain, from 23 to 26 August. The results of two large Phase IV trials showed that while pramipexole significantly improves the characteristic symptoms of RLS among patients with moderate to severe RLS, it also demonstrated significant beneficial effects on associated symptoms such as limb pain and health-related quality of life, including associated mood disturbance. Limb pain and mood disturbance are important secondary ailments commonly experienced by RLS patients, and these studies are the first in which an approved RLS treatment has demonstrated benefits addressing these symptoms in a clinical study in RLS patients... Boehringer Ingelheim's Press Release - Boehringer Ingelheim's Press Release -

GlaxoSmithKline and Actelion : exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond

Monday 14 July 2008 - GlaxoSmithKline and Actelion to potentially co-develop and co-commercialise other orexin receptor antagonists - GlaxoSmithKline (GSK) and Actelion Ltd (SWX: ATLN) announced that they have entered into an exclusive worldwide collaboration (excluding Japan) for Actelion’s almorexant, an orexin receptor antagonist in phase III development with first-in-class potential as a treatment for primary insomnia.

Under the terms of the agreement, GSK will receive exclusive worldwide rights to co-develop and co-commercialise almorexant. Actelion will continue to lead the ongoing development programme and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40 per cent of the costs. Almorexant will also be studied in other orexin-related disorders and all costs related to these programmes will be shared equally... GlaxoSmithKline's Press Release - Actelion's Press Release -

SRI International : Research Team Identifies Rare Sleep-Activated Neurons in the Cerebral Cortex

July 21, 2008 - Findings May Have Important Implications for Treatment of Sleep Disorders and for Understanding Mood and Memory – SRI International announced that a research team has identified the first example of neurons that are activated in the cerebral cortex during slow wave sleep (SWS). The research, led by Dmitry Gerashchenko and Thomas Kilduff, will be published in the Proceedings of the National Academy of Sciences (PNAS) in a paper titled Identification of a Population of Sleep-Active Cerebral Cortex Neurons. The paper is available via the PNAS Web site starting July 21.

The presence of slow waves in the electroencephalogram (EEG) is the distinctive “signature” of SWS and a type of activity that does not normally occur during wakefulness. For years, researchers have hypothesized that ‘slow-wave activity’ (SWA) is correlated with the recuperative properties of sleep and the brain’s ability to learn, in part, because brain cells are relatively quiet during this time. While populations of neurons activated during sleep have been identified in the forebrain and the hypothalamus, up until this point, neurons in the cortex have been seen as dormant. These new results show that a group of rare neurons are active, rather than at rest, during SWS... SRI International's Press Release -