Somaxon Pharmaceuticals Announces FDA Feedback on Silenor OTC Regulatory Pathway and Changes to Commercial Team

Somaxon Pharmaceuticals

today announced that it recently had a meeting with the U.S. Food & Drug Administration relating to the over-the-counter development program for Silenor. In the meeting, which Somaxon attended jointly with its Silenor partner Procter & Gamble, the FDA provided clinical and regulatory guidance that the company believes provides a clear path forward toward an OTC version of Silenor. Somaxon believes that the FDA's guidance provides an opportunity to develop an OTC label that is tailored to Silenor's clinical profile and differentiated from other OTC sleep products. Somaxon believes that Silenor's characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product.