Another Phase III trial of Somaxon's insomnia drug Silenor has produced more data supporting its statistically significant results in patients. In a late-stage trial of 255 elderly volunteers with a minimum three-month history of insomnia, the drug met its primary and secondary endpoints. The primary endpoint was total sleep time. Silenor also proved a winner in a Phase III trial last April. Somaxon was a 2005 Fierce 15 [1] company.
"With this positive Silenor data we are nearing completion of our Phase III clinical development program. We look forward to the results of our final Phase III clinical trial, which we expect in December, the continuation of ongoing strategic collaboration discussions and a New Drug Application filing targeted for the third quarter of 2007."
- see the release [2] on the trial results
Related Article:
Somaxon touts mid-stage data on smoking cessation. Report [3]
Links:
[1] http://www.fiercebiotech.com/Fierce15/2005/
[2] http://www.fiercebiotech.com/story/press-release-silenor-demonstrates-positive-results-in-third-phase-3-trial/2006-11-19
[3] http://www.fiercebiotech.com/story/somaxon-touts-mid-stage-data-on-smoking-cessation/2006-07-26