Positive results from SKP-1041 Phase 2 study in insomnia patients with MOTN awakenings

Jun 16 2011

Results of a Phase 2 study sponsored by Somnus Therapeutics, Inc., add further evidence supporting the efficacy and safety of a novel bedtime therapeutic that addresses a major underserved need of insomnia patients: maintaining sleep. SKP-1041, a modified-release formulation of zaleplon, is designed to accomplish this by reducing middle-of-the-night (MOTN) awakenings without interfering with natural sleep onset and early deep sleep. At all three doses tested, SKP-1041 significantly reduced time spent awake during the night compared to placebo, with no evidence of next-morning adverse cognitive effects.

"In this study, we saw statistically significant reductions in the time spent awake during the night (WASO) for all three dosage strengths tested. For the 15 and 20 mg doses, there was a significant reduction in the number of middle-of-the-night awakenings during hours 3-7 of the 8-hour sleep period (NAASO_3-7) as well as increased total sleep time for hours 3-7 (TST _3-7)," said study investigator Russell Rosenberg, Ph.D., CEO NeuroTrials Research, and the Atlanta School of Sleep Medicine. "Blood levels of zaleplon were measured over 8 hours and confirmed the release of active drug starting 2 hours after ingestion. This facilitates peak hypnotic efficacy during the hours when unwanted awakenings are most likely to occur. (see Figure 1) Using the Digit Symbol Substitution Test (DSST) and Digit Span Test (DST) to test for next-day effects on cognition, we saw no impairment compared to placebo at all three doses."

"The SKP-1041 formulation is engineered to deliver a short-acting agent, zaleplon, only during the time needed to maintain sleep. All of our clinical studies have confirmed that the formulation works as designed," said Gary Cupit, PharmD, Chief Executive Officer of Somnus Therapeutics. "We have seen consistent and reliable pharmacokinetics throughout our 3 Phase 1 studies and in the PK investigations of Phase 2. Furthermore, the formulation is well-tolerated. Adverse events in (the) more than 130 subjects included in our Phase 1 and 2 studies have been reported to be not significantly different from placebo. This is in addition to many years of safety data accumulated on immediate release zaleplon in clinical trials and over more than a decade on the market."