Somaxon Pharma (SOMX) Resubmits NDA to FDA for Silenor(R)
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Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that it has resubmitted its New Drug Application to the U.S. FDA for Silenor(R) (doxepin) 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 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months.
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