Somaxon resubmits new drug application for insomnia drug

Somaxon Pharmaceuticals, a specialty pharmaceutical company, has resubmitted its new drug application to the FDA for Silenor for the treatment of insomnia.

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, or ECG effects.

The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6mg or under exaggerated exposure conditions of 50mg. The FDA has indicated that the review cycle for the resubmission will be six months.

Richard Pascoe, president and CEO of Somaxon, said: "We are confident that the additional clinical efficacy data analyses included in the resubmission demonstrate sustained subjective sleep maintenance efficacy in adults. Based on those analyses, as well as the favorable results from our ECG study, we believe that the resubmission can support a determination by the FDA that Silenor be approved for the treatment of insomnia."

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