Shares of Somaxon Pharmaceuticals Inc., a specialty pharmaceutical company, opened sharply higher in today’s trading after the company announced FDA feedback on the over-the-counter (OTC) development program for Silenor®.
At last check, Somaxon shares were trading 13.75% higher at $0.91.
Somaxon said that in a recent meeting with the FDA, which was also attended by Silenor partner Procter & Gamble (NYSE: PG), the agency provided clinical and regulatory guidance that offers a clear path toward an OTC version of Silenor.
The company believes that the FDA’s feedback offers a chance to develop an OTC label that is tailored to Silenor’s clinical profile and is different from other OTC sleep products.
Somaxon also announced some changes to its commercial team promoting Silenor for the treatment of insomnia. The company said that it altered its Co-Promotion Agreement with Procter & Gamble following which Procter & Gamble’s exclusive negotiation period relating to OTC rights to Silenor is extended from 60 to 120 days. The company also appointed Michael Allen as senior vice president for Sales and Marketing, replacing Jeff Raser.
Richard W. Pascoe, president and CEO of Silenor, said that the company’s first year of marketing Silenor provided it with a host of learnings relating
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