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505(b)(2) IV Acetaminophen

Cadence Pharmaceuticals announced yesterday 5/14/2009 that it had submitted an NDA for Acetavance(TM) – intravenous acetaminophen.  It is instructive to look at the clinical development plan for this 505(b)(2) product.  According to the company, the FDA required 2 pivotal Phase 3 trials: one clinical trial for the treatment of acute pain in patients following orthopedic surgery and one clinical trial for the treatment of endotoxin-induced fever. In addition, “[the] NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 children.”

The need for 2 pivotal Phase 3 trials in pain drugs is standard.  The choice of clinical endpoints depends on the type of pain drug.  In this case, acetaminophen is an antipyretic, so reduction in fever was an obvious endpoint.  FDA guidance exists for NSAIDs and opioids as well.

Cadence obtained the product from Bristol-Myers Squibb which has approval and markets the drug in Europe and other countries. Thus, Cadence had access to BMS studies.