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news.Somaxon has reported that its insomnia drug Silenor was effective at improving sleep onset in a phase III clinical trial.
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Results demonstrated that 6mg of Silenor was effective at inducing sleep and maintaining sleep throughout the night.
There was a measured improvement of sleep time of 51 minutes compared to placebo. The study also demonstrated that Silenor was well tolerated.
“We are hopeful that Silenor can become the first non-scheduled insomnia treatment to help patients fall asleep and maintain sleep throughout the night This transient insomnia result is also important because our patent covering the use of Silenor in patients with transient insomnia extends until 2020,” said Ken Cohen, Somaxon's President and CEO
The company said it expects results from its remaining two phase III clinical trials for Silenor by the end of this year. If the company's ongoing phase III clinical trials and planned preclinical studies for Silenor are successful, Somaxon expects to file a new drug application with the FDA in the third quarter of 2007.