Thursday, Somaxon Pharmaceuticals, Inc. (SOMX) announced that it has resubmitted its New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for Silenor for the treatment of insomnia.
The resubmission includes further statistical analyses of the company's clinical data relating to the durability of subjective sleep maintenance efficacy, and the findings 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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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.