Biovail tramadol ER needs more data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Biovail expects to submit data from a new clinical trial of its orally disintegrating extended-release tramadol product in late 2005/early 2006, the firm said March 30. The announcement follows initial feedback from FDA regarding Biovail's March 2005 complete response to an October 2004 "approvable" letter for the opioid analgesic. "Upon preliminary review, [FDA said] it is of the opinion that additional clinical trial data will be required," the company said. Biovail maintains that its 505(b)(2) NDA is sufficient and plans to meet with FDA to discuss its options. The setback could allow Labopharm to file its extended-release tramadol ahead of Biovail; the Canadian firm previously projected a second-half 2005 filing (1Pharmaceutical Approvals Monthly October 2004, p. 7)...