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 nonelderly 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.
“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, CEO 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, PhD, will present pharmacodynamic data from SOM201 in a late-breaker platform session on Wednesday, June 15 at 1 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.”
Zaleplon is a non-benzodiazepine GABA agent with a short half-life (~1 hour), and little or no residual hypnotic effect upon awakening. 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.