Alkermes Submits Vivitrol Complete Response
This article was originally published in The Pink Sheet Daily
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Alkermes could still be on track for a second quarter launch of its alcohol dependence therapy Vivitrol (naltrexone) after submitting a complete response to an FDA "approvable" letter Feb. 17. The firm expects FDA to designate the filing as a Class I resubmission, under which the agency would have 60 days to review the response from the time of submission. Alkermes said the response includes some additional data, but did not require further clinical studies. The late-December approvable letter requested additional preclinical pharmacokinetic data and resolution of final labeling (1 (Also see "Alcohol Dependence Treatment Vivitrol “Approvable”" - Pink Sheet, 29 Dec, 2005.)). The firm submitted an NDA for the once-monthly injection in March 2005 for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support. |