Cadence Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational product, Acetavance (acetaminophen), for the treatment of acute pain and fever in adults and children. The NDA submission includes data from a pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever. 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, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside the United States.
Acetavance is an intravenous acetaminophen being developed to treat pain or fever in hospitalized patients who cannot take oral medications.
For more information call (858) 436-1400 or visit www.cadencepharm.com.