Somaxon, a specialty pharmaceutical company has announced that it has resubmitted New Drug Application (NDA) to FDA for Silenor (doxepin) for the treatment of insomnia.
The resubmission includes additional statistical analyses of the clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the 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.
Richard Pascoe, President and CEO of Somaxon, said: “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.”
“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.”