Ph III Silenor data confirms positive data package

The USA's Somaxon Pharmaceuticals has reported strong data from three Phase III clinical trials of Silenor (doxepin HCl) for insomnia at the American Psychiatric Association's annual meeting, in Washington DC.

The findings are a subset of the data from Somaxon's completed Phase III development program, which comprised four Phase III trials evaluating Silenor, a low-dose (1mg-6mg) formulation of doxepin for the treatment of insomnia. As the company has previously reported, all of these clinical trials demonstrated statistically-significant differences relative to placebo for their primary endpoints and multiple secondary endpoints. The clinical trials demonstrated significant and clinically-meaningful improvements in sleep onset, sleep maintenance and the prevention of early morning awakenings.

In addition, the side effect profile was comparable to placebo, and there were no reports of amnesia, hallucinations or complex sleep behaviors. There were no next-day residual effects found at what are expected to be the recommended starting doses, and there was no apparent evidence of anticholinergic effects (eg, dry mouth), tolerance, rebound insomnia, withdrawal effects or weight gain as compared to placebo.