FDAnews
www.fdanews.com/articles/97929-cadence-pharmaceuticals-completes-enrollment-for-iv-acetaminophen-trial

Cadence Pharmaceuticals Completes Enrollment for IV Acetaminophen Trial

August 31, 2007

Cadence Pharmaceuticals reported it has completed patient enrollment in a pivotal Phase III clinical trial to evaluate its investigational product candidate, intravenous (IV) acetaminophen, for the treatment of acute pain following gynecologic surgery.

The randomized, double-blind, placebo-controlled IV APAP 301 study in which a total of 331 subjects have been enrolled at 27 sites throughout the U.S., Cadence said.

Treatment will consist of either IV acetaminophen or placebo in the 48-hour period following gynecologic surgery. The primary endpoint of the trial is analgesic efficacy, measured by reduction in pain intensity compared with placebo, the company added.