Somaxon re-files Silenor NDAOn June 4, 2009, Somaxon (SOMX) announced that is has resubmitted the new drug application (NDA) to the U.S. FDA for Silenor (doxepin) for the treatment of insomnia. The submission comes roughly three and a half months after the FDA issued a Complete Response Letter (CRL) in late February 2009, and two months after management met with the FDA in early April 2009 to discuss the issues raised in the CRL.The resubmission includes additional statistical analyses of the company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the company's completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg....

FDA Rejects Somaxon's Silenor for Insomnia -- Stock HammeredOn February 26, 2009, after the market closed, the FDA notified Somaxon Pharmaceuticals, Inc. (SOMX) that it could not approve Silenor (doxepin) for the treatment of insomnia. In the Complete Response letter, the FDA raised a number of issues relating to the interpretation of the efficacy data contained in the Silenor new drug application (NDA).The FDA did indicate, however, that it was open to a discussion of these concerns. The FDA did not specifically request the company to conduct additional clinical trials of Silenor, but Somaxon management believes that a discussion with the FDA will be necessary to gain a complete understanding of the implications for the rejection letter.In afterhours trading, Somaxon's stock is down 53% to $1.01.In a research report published at the beginning of February entitled, "Cautious Going Into Silenor ...