Naproxcinod regulatory update

NicOx withdrew an MAA in Europe for naproxcinod to treat signs and symptoms of osteoarthritis of the knee and hip in adults. The company said EMA's CHMP indicated that the committee would not issue a positive opinion for the application, which was submitted in December 2009. NicOx is evaluating options for further development of the product. In the U.S., NicOx is appealing a 2010 complete response letter from FDA for naproxcinod. In the letter, FDA asked for 1 or more long-term controlled studies to assess cardiovascular and gastrointestinal safety of the compound (see BioCentury, July 26, 2010). ...