Somaxon Pharmaceuticals Announces FDA Feedback On Silenor OTC Regulatory Pathway And Changes To Commercial Team
Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company, today announced that it recently had a meeting with the U.S. Food & Drug Administration (FDA) relating to the over-the-counter (OTC) 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.
Somaxon also announced changes to its commercial team that promotes Silenor for the treatment of insomnia characterized by difficulty with sleep maintenance. In particular, Somaxon announced that:
- it has amended the Co-Promotion Agreement with Procter & Gamble so that Procter & Gamble’s exclusive negotiation period relating to OTC rights to Silenor is extended from 60 to 120 days, and to discontinue the co-promotion services under the agreement as of December 31, 2011.
- it has appointed Michael Allen as Senior Vice President, Sales and Marketing. Mr. Allen replaces Jeff Raser, who has resigned from the company to pursue other interests.
- it has provided notice to Publicis Touchpoint Solutions, Inc. that it intends to hire the Publicis sales force promoting Silenor as Somaxon employees during the fourth quarter of 2011. In connection with the conversion of the sales force, Somaxon will terminate the Professional Detailing Services Agreement with Publicis effective as of December 31, 2011.
“Our first year of marketing Silenor has provided us with a host of learnings relating to the market and the most efficient use of our resources to promote Silenor for the treatment of insomnia,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “We believe that the changes we are announcing today will enable us to focus our sales and marketing resources in the most efficient and effective way as we move forward through the fourth quarter and into 2012.”
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