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Somaxon Could Fold Gambling Drug Development Following Negative Trial Results

This article was originally published in The Pink Sheet Daily

Executive Summary

Company will also assess results of nalmefene studies in smoking cessation before deciding on drug’s future.

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Silenor "Complete Response" Letter Hints At Efficacy Issues

Somaxon's last-minute conference call announcing FDA's "complete response" letter for the insomnia agent Silenor (doxepin) did little to clarify whether the agency's concerns have to do with efficacy issues or whether FDA just wants more data on doxepin's potential to prolong the QT interval. Somaxon announced the action letter late on Feb. 26

Silenor "Complete Response" Letter Hints At Efficacy Issues

Somaxon's last-minute conference call announcing FDA's "complete response" letter for the insomnia agent Silenor (doxepin) did little to clarify whether the agency's concerns have to do with efficacy issues or whether FDA just wants more data on doxepin's potential to prolong the QT interval. Somaxon announced the action letter late on Feb. 26

Silenor “Complete Response” Letter Hints At Efficacy Issues

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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