SAN DIEGO, April 10 (UPI) -- Somaxon said Monday its potential insomnia treatment Silenor improved sleep in a phase 3 study.
The company said it will release results from other phase 3 trials later this year and anticipates filing a new drug application in the first quarter of 2007.
Ken Cohen, Somaxon's president and chief executive officer, said Silenor has a mechanism of action that is distinct from benzodiazepine and non-benzodiazepine medications for insomnia and the company is aiming to get the drug approved as a first-line treatment.
In the study, adults with chronic insomnia treated with Silenor showed improvement in eight-hour wake after sleep onset time and total sleep time compared to placebo.
The drug was well-tolerated, with side effects that were comparable to placebo. The study did not find any evidence of tolerance to Silenor.
