Silenor Approaching FDA Decision Date (SOMX)

Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company that focuses on in-licensing, developing and bringing to market treatments for psychological and neurological disorders, has announced that the US Food and Drug Administration (FDA) had given it a new Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2009 after accepting its resubmitted New Drug Application (NDA) for Silenor® (doxepin) for treating insomnia.

The announcement was made in a July 7 press release where the company acknowledged that it had entered…

@@CalendarRight@@ “…into a purchase agreement to issue and sell in a private placement approximately 5.1 million shares of its common stock and warrants to purchase up to approximately 5.1 million additional shares of its common stock, for aggregate gross proceeds of approximately $6 million”.

Some of its financers were MPM Capital, Tavistock Life Sciences, Scale Venture Partners, Montreux Equity Partners, Prospect Venture Partners, and Domain Associates.

“Based on our current operating plan, we expect that the cash raised in this financing, together with our existing resources, will allow us to operate our business through the FDA review cycle of the NDA resubmission and extend our cash runway through the second quarter of 2010,” said Richard W. Pascoe, Somaxon’s President and CEO.

@@AdsenseLeft@@ Somaxon submitted its first NDA on January 31, 2008.  However, it had to resubmit its NDA on June 4, 2009 after receiving a Complete Response Letter from the FDA. In the letter, the FDA denied approval for the insomnia drug Silenor in its present form since it lengthened the cardiac QT interval, which in turn caused irregularities in the heart’s electrical system. In the resubmitted NDA, Somaxon presented statistical results of clinical trials in which it was shown that Silenor did not affect QT interval prolongation if administered at 6 mg or 50 mg.

“We believe that this resubmission fully addresses all of the issues raised in the Complete Response Letter that we received from the FDA on February 25, 2009 and further clarified in our meeting with the FDA on April 6,” confirmed Pascoe.

Doxepin is a potent H1 antagonist and has a high affinity for human H1 receptors and not for other central nervous system targets. This makes it a potential drug for treating insomnia if administered in low doses. Insomnia has become an issue of great concern in the United States since according to the National Sleep Foundation almost 70 million Americans have insomnia.