Elan Prialt amendment
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Elan expects to launch its non-opioid analgesic Prialt (ziconotide) in early 2005 following a June 28 amendment that is expected to receive a six-month review. The submission includes a 21-day trial (conducted in response to a July 2001 "approvable" letter) showing statistically significant results "at lower doses and following a slower titration schedule" than previously studied, Elan says. Prior studies focused on cancer, AIDS and neuropathic pain (1Pharmaceutical Approvals Monthly Jan. 1, 2004, p. 20). Elan is seeking approval for severe chronic pain...
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