Somaxon reports positive results for insomnia drug

This phase III trial was designed to assess the efficacy and safety of Silenor in elderly patients with primary sleep maintenance insomnia.

Silenor demonstrated a statistically significant improvement compared to placebo in the primary endpoint of this trial, subjective total sleep time. Statistical significance was maintained for all time points measured throughout the four-week treatment period. This clinical trial demonstrated that Silenor was well tolerated.

“As in all of our prior trials, Silenor achieved statistically significant improvements compared to placebo for the primary endpoint. We have now reported results from five randomized, placebo-controlled clinical trials of Silenor, with consistent and reproducible effects shown in both the adult and the elderly insomnia populations, and in both outpatient and sleep laboratory settings,” said Phil Jochelson, chief medical officer of Somaxon.

“We look forward to the results of our final phase III clinical trial, which we expect in December, the continuation of ongoing strategic collaboration discussions and a new drug application filing targeted for the third quarter of 2007,” added Ken Cohen, Somaxon’s president and CEO.