CiltyriTreatment for Insomnia
Complete Response Letter for Ciltyri
Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission
BRIDGEWATER, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin (Ciltyri ). Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.
Sanofi-aventis is currently reviewing the content of the complete response letter, in which the FDA has requested additional information regarding benefit-risk. The company will contact the FDA in the coming days to request a meeting to discuss what steps and data would be needed for approval.
About eplivanserin (Ciltyri)
Eplivanserin, discovered and developed by sanofi-aventis, is a serotonin type 2 A receptor antagonist, and unlike benzodiazepine-receptor agonists (BzRAs), has no affinity for GABA receptors. It has been studied in a clinical development program including nearly 3,000 patients.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY) . For more information, visit: www.sanofi-aventis.us or www.sanofi-aventis.com
Forward Looking Statements
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CONTACT: U.S. Media, Susan Brooks, +1-908-981-6566,
Web Site: http://www.sanofi-aventis.us/
Posted: September 2009