Tuesday, Somaxon Pharmaceuticals, Inc. (SOMX) provided an update on the status of its New Drug Application or NDA for Silenor 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 NDA and indicated that the FDA was open to a discussion of these concerns.
the FDA stated that to obtain approval of a chronic insomnia treatment, objective and subjective efficacy must be established in adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined as at least one month.
Based on the feedback it received at the meeting, Somaxon plans to conduct additional analyses of its clinical data focused on the durability of subjective sleep maintenance efficacy in adults with primary insomnia. The company will complete these analyses as soon as possible.
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