Somaxon believes that the product has potential to become a significant participant in the insomnia market.
With the conclusion of this trial, Somaxon has completed six clinical trials with Silenor for the treatment of insomnia, including four phase III trials. In each of these clinical trials, Silenor demonstrated statistically significant results in the trial’s designated primary endpoint. These endpoints included measures of both sleep maintenance and sleep onset.
In this particular trial, Silenor demonstrated a statistically significant improvement compared to placebo in the primary endpoint, time spent awake after sleep onset as measured at night one, for two doses studied. Statistical significance for this endpoint was also achieved at the end of the twelve week treatment period.
The company anticipates filing a new drug application with the FDA in the third quarter of 2007.