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No aid for sleepless in Paris

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sanofi-Aventis received an FDA "complete response" letter for its novel insomnia candidate eplivanserin, the firm announced Sept. 16. The firm said only that FDA is asking for additional information regarding the benefit-risk profile of the serotonin type 2A receptor antagonist. Sanofi is seeking approval to treat patients with chronic insomnia characterized by difficulties with sleep maintenance, a unique claim that could help distinguish a new entrant in a crowded market. The setback is especially critical because the firm faces generic competition for its big money maker in the insomnia market, Ambien, which went off patent in 2007 and saw the launch of its first branded competitor Edular earlier in September by Meda Pharmaceuticals (2"The Pink Sheet" DAILY, Sept. 9, 2009). Sanofi previously had a back-up compound in development - volinanserin - but terminated clinical trials after the compound failed to show efficacy in primary insomnia with predominant sleep maintenance problems

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