ARTICLE | Company News

Naproxcinod receives complete response

July 23, 2010 12:33 AM UTC

NicOx S.A. (Euronext:COX) fell EUR 0.60 (21%) to EUR 2.24 on Thursday after FDA issued a complete response letter for an NDA for naproxcinod to treat the signs and symptoms of osteoarthritis. In the letter, FDA recommended NicOx conduct one or more long-term controlled studies to assess cardiovascular and gastrointestinal safety of naproxcinod. 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. ...