Alkermes Vivitrol "complete response"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Alkermes' alcoholism treatment Vivitrol (extended-release naltrexone injection) could be approved as early as April if FDA accepts the firm's response to a Dec. 28, 2005 "approvable" letter as a Class 1 response. The response, announced Feb. 17, includes some additional data but no additional clinical studies. The approvable letter requested preclinical pharmacokinetic data to support reference to existing oral naltrexone preclinical data via Vivitrol's 505(b)(2) NDA (1Pharmaceutical Approvals Monthly January 2006, p. 28)…