Silenor “Complete Response” Letter Hints At Efficacy Issues
This article was originally published in The Pink Sheet Daily
Executive Summary
Somaxon will meet with FDA to clarify what the issues for its insomnia agent are, but says an additional trial was not specifically requested; additional QT data is ready to submit.
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Somaxon Sleep Aid Silenor Not Effective, FDA Says
In its second "complete response" letter for the chronic insomnia drug, FDA says Silenor fails to meet approval standards.
Silenor approval path clarified, narrowed
Somaxon will have to re-analyze the clinical data on its insomnia agent Silenor (doxepin) to see whether it can re-submit the application for chronic insomnia. After meeting FDA to discuss the "complete response" letter issued in late February, Somaxon is conducting additional analyses of its clinical data on the durability of sleep maintenance and, if they meet FDA's requirements, will include that in a re-submission. The complete response letter raised both efficacy issues and QT prolongation, but FDA has accepted the ECG study already submitted (1"The Pink Sheet" DAILY, Feb. 27, 2009). Regarding the efficacy issues, which Somaxon had hoped to further elucidate with FDA, the company said FDA was clear that for chronic insomnia, objective and subjective efficacy must be shown in adult and elderly populations at both the beginning of treatment and on a persistent basis, defined as at least one month. The firm also said it will not pursue approval of a claim that Silenor improves sleep onset, and will abandon the 1 mg dose (the lowest submitted)