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NicOx SA today announced the receipt of a Complete Response Letter from the US Food and Drug Administration (FDA) related to the New Drug Application (NDA) for naproxcinod. Naproxcinod is being developed for the relief of the signs and symptoms of osteoarthritis.
The FDA informed NicOx that its review of the NDA is complete and that it does not approve the naproxcinod application. The FDA has recommended conducting one or more long-term controlled studies to assess the cardiovascular and gastrointestinal safety of naproxcinod. Additional studies to demonstrate a clinically meaningful therapeutic benefit attributable to the nitric oxide donation were also recommended. No clinical efficacy studies were requested.
NicOx plans to discuss the Complete Response Letter and potential next steps as early as possible with the FDA.
The naproxcinod Marketing Authorization Application (MAA) submitted by NicOx in December 2009 is currently under review by the European Medicines Agency (EMA).
NicOx remains well funded and had cash, cash equivalents and financial instruments of EU138.5 million at the end of March 2010. The Company will publish its financial results for the first half of 2010 on July 30, 2010.
NicOx has no long term debt and is constantly reviewing all aspects of its cost base to ensure careful conservation of its funds.
NicOx has a broad pipeline of nitric oxide (NO)-donating New Molecular Entities (NMEs) targeting the therapeutic areas of inflammatory, cardiometabolic and ophthalmological diseases. NicOx has built a network of strong partnerships for the development of some of its promising lead compounds, including alliances with Merck & Co., Inc., Bausch + Lomb and Ferrer.