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Somaxon plans to report data from three phase 3 Silenor clinical trials in Q4
By Jennifer Lanning Drey
Eugene, Ore., Sept. 6 - Somaxon Pharmaceuticals, Inc. expects to report new data from three phase 3 clinical trials of Silenor (doxepin Hcl) in the fourth quarter, Somaxon's president and chief executive officer Kenneth Cohen said Wednesday at the Thomas Weisel healthcare conference.
The company reported positive results from an initial phase 3 clinical trial of the drug earlier this year.
Silenor is being developed as a treatment for insomnia. Somaxon has tested the drug at 1 mg, 3 mg and 6 mg doses and believes that the possibility for low dosages underlies its basis for a strong patent position.
"At these low doses, we see the benefits that we want in sleep, but we don't see significant side effects during the day," Cohen said.
"What we have is not simply an older generic drug, but we have it available in a patented and otherwise unavailable low-dosage strength," he also said.
Somaxon previously reported that patients who participated in the first phase 3 clinical trial of Silenor saw an improvement in mean Wake After Sleep Onset of 26 minutes for 3 mg and 31 minutes for 6 mg versus those on placebo for the primary analysis.
In addition, after four weeks of nightly administration, improvement in Total Sleep Time remained statistically significant for both doses relative to the placebo, the company previously said.
"We believe that Silenor offers the potential to significantly differentiate itself from the competition," Cohen said Wednesday.
The company plans to file a New Drug Application with the Food and Drug Administration for Somaxon in the third quarter of 2007.
Somaxon expects to enter into a strategic partnership prior to the NDA filing, Cohen said.
Somaxon is a San Diego specialty pharmaceutical company focused on the fields of psychiatry and neurology.
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