NicOx was informed by the FDA that the review of the NDA is complete and that it does not approve the Naproxcinod application.
FDA has recommended NicOx to conduct one or more long-term controlled studies to assess the cardiovascular and gastrointestinal safety of Naproxcinod.
Studies to demonstrate a clinically meaningful therapeutic benefit attributable to the nitric oxide donation were also recommended. No clinical efficacy studies were requested.
NicOx is planning to discuss the complete response letter and next steps as early as possible with the FDA.
NicOx has submitted a marketing authorization application (MAA) for Naproxcinod in December 2009 which is currently under review by the European Medicines Agency.