Somnus Therapeutics Completes Successful Phase 2 Study Of SKP-1041 For Sleep Maintenance Insomnia

Main Category: Sleep / Sleep Disorders / Insomnia
Article Date: 02 Jun 2011 - 5:00 PDT


Somnus Therapeutics, Inc., a private specialty pharmaceutical company, has completed a Phase 2 dose-ranging study of SKP-1041, a modified-release formulation of zaleplon. The study (SOM201), conducted in non-elderly adults with primary insomnia characterized by middle-of-the-night (MOTN) awakening, was a double-blind, placebo-controlled, crossover trial of three doses (10, 15, and 20 mg) of SKP-1041, a modified-release formulation of zaleplon (more below).

"Middle-of-the-night awakening remains the biggest unmet need in insomnia-one growing with an aging population-while few marketed drugs carry a sleep maintenance label," said Gary Cupit, Chief Executive Officer of Somnus Therapeutics. "We are gratified that the SOM201 study met the primary endpoint for wake after sleep onset (WASO) with no unwanted next-day cognitive or motor effects. SKP-1041 is specifically designed to help patients who fall asleep normally but have difficulty sleeping through the night and thus want a medication that will not disturb their natural early stage sleep while allowing them to awaken refreshed and ready to face the next day."

Two presentations are scheduled at SLEEP 2011. A poster: "Pharmacokinetic Profile of a Modified Release Formulation of Zaleplon (SKP-1041) 10.0 mg, 15.0 mg, and 20.0 mg in Adults with Primary Sleep Maintenance Insomnia" will be presented on Monday, June 13. Study investigator Russell Rosenberg, Ph.D., CEO NeuroTrials Research, and the Atlanta School of Sleep Medicine, will present pharmacodynamic data from SOM201 in a late-breaker platform session on Wednesday, June 15 at 1:00 PM, entitled: "SKP-1041, a Novel Modified-Release Formulation of Zaleplon, Significantly Improves Sleep in Patients with Middle-of-the-Night Awakening: Results of a Phase II, Double-Blind, Crossover, Placebo-Controlled, Dose-Ranging Trial".

About MOTN Awakening

More than 40 million people in the US, EU and Japan suffer from insomnia. The majority of people with insomnia can fall asleep naturally but have difficulty maintaining sleep throughout the night, and prevalence increases with age. Waking during the night has been reported in approximately one-third of the general population and may be associated with daytime fatigue and cognitive impairment. Data available in the last few years show a significant association between insomnia and comorbidities, including obesity, mood disorders, and chronic pain.

About Zaleplon

Zaleplon is a non-benzodiazepine GABA agent with a short half-life (~1 hour), and little or no residual hypnotic effect upon awakening. It has been marketed since 2000 in Sonata®, as a 5 mg and 10 mg immediate-release capsule for the treatment of sleep-onset insomnia. With a pharmacokinetic profile characterized by rapid absorption and elimination, zaleplon effectively induces sleep without unwanted residual effects, but because of its short half-life, is not routinely used to treat sleep maintenance.

About SKP-1041

SKP-1041 uses SkyePharma's Geoclock™ technology to delay and sustain the release of zaleplon after bedtime administration. This delivery approach is designed to treat people who have difficulty maintaining sleep after falling asleep naturally, both allowing natural sleep induction and preventing middle-of-the-night awakening without residual effects. In June 2007, Somnus entered into an exclusive license with SkyePharma for the worldwide development and commercialization of SKP-1041. Under the agreement, SkyePharma will formulate and manufacture the product and Somnus will seek a partner to develop and commercialize it.

About the Geoclock™ controlled-release technology

The proprietary Geoclock™ (SkyePharma PLC, LSE: SKP) delivery system is a unique technology that allows delivery of a drug over a preset time period in a chronotherapy-focused press-coated tablet, with active drug loaded inside an outer tablet layer formulated to produce a pH-independent lag time prior to core drug delivery.

Source:
Somnus Therapeutics, Inc.

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