Somnus completes Phase I study of sleep maintenance drug

The Phase I study was a single-center, double-blind, placebo-controlled crossover study with an open-label positive control arm to investigate the pharmacokinetic and pharmacodynamic profile of single oral doses of alternative zaleplon prototypes in 19 healthy subjects aged between 20-50 years.

In June 2007, Somnus entered into an exclusive agreement with SkyePharma for the worldwide development and commercialization of SKP-1041. Under the terms of the licensing agreement between SkyePharma and Somnus, a $1 million milestone payment is now payable to SkyePharma.

SKP-1041 is a new formulation of zaleplon, a non-benzodiazepine hypnotic agent, which utilizes SkyePharma’s proprietary Geoclock technology for controlled release. The formulation is designed to treat people who have difficulty maintaining sleep but not with sleep onset and is intended to prevent middle-of-the-night awakening while avoiding next-day hangover effects.

Ken Cunningham, CEO of SkyePharma, said: We are delighted with the successful completion of the Phase I study for SKP-1041 by Somnus. Both companies are confident that the Geoclock version of zaleplon has the potential to provide major benefits through controlled release, to help provide a good night’s rest, as well as validating our formulation and controlled-release technologies.

We believe SKP-1041 could generate significant sales in the large but poorly served sleep maintenance market, where there is a clear need for a product which allows deep sleep early and maintains sleep through the night, with no cognitive impairment or daytime drowsiness.