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Meda's Edluar Is First Alternative Form of Generic Ambien To Hit Insomnia Market

This article was originally published in The Pink Sheet Daily

Executive Summary

Lozenge form of zolpidem tartrate is the first of several new versions of Ambien that could launch in the coming months.

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Sleepless Nights: Sanofi-Aventis Gets "Complete Response" Letter For Insomnia Drug

FDA asks Sanofi for more benefit-risk information for eplivanserin before approval.

Sleepless Nights: Sanofi-Aventis Gets "Complete Response" Letter For Insomnia Drug

FDA asks Sanofi for more benefit-risk information for eplivanserin before approval.

No aid for sleepless in Paris

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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