Somaxon (finally) wins FDA approval for sleep drug Silenor

San Diego-based Somaxon has won FDA approval of its sleep drug Silenor, completing a long and financially exhausting quest that has consumed more than $170 million. The third time proved the charm for Somaxon, which had tried and failed twice before to gain an approval, only to be frustrated by repeated questions about the drug's sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. And despite the approval, the developer is still searching for a partner on the program.

"Looking forward, we will continue to execute on our business strategy, focusing on seeking a U.S. commercial partnership, building a U.S. commercial presence and preparing to launch Silenor in the second half of 2010," said CEO Richard W. Pascoe. "We believe that Silenor's ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential uniquely positions Silenor for commercial success."

Despite Pascoe's bullish sentiments about marketing potential, though, Somaxon has long been out in search of a partner on the drug. Interim CEO David F. Hale said back in May of 2008 that the company had lined up $65 million in new financing to help with marketing the drug, which the company could rely on as it engaged in partnering talks. The developer reportedly has a little over $5 million in the bank. And it is entering a field already crowded with other products.

Nevertheless, executives could raise their champagne glasses this morning as the developer's share price (SOMX) shot up 80 percent on the news.

- check out Somaxon's release