ARTICLE | Clinical News

Naproxcinod regulatory update

July 26, 2010 7:00 AM UTC

FDA issued a complete response letter for an NDA for naproxcinod to treat signs and symptoms of osteoarthritis (OA). In the letter, FDA recommended NicOx conduct 1 or more long-term controlled studies to assess cardiovascular and gastrointestinal safety of the compound. The agency also recommended additional studies to demonstrate a clinically meaningful therapeutic benefit attributable to nitric oxide donation. NicOx said it will discuss the letter and next steps with FDA as early as possible. ...