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NicOx's naproxcinod delayed by FDA

The US Food and Drug Administration has told NicOx that it will not approve the New Drug Application for naproxcinod without further data

French pharma company NicOx has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its investigational osteoarthritis drug naproxcinod – the firm's lead drug candidate. The letter states that the federal agency will not approve the New Drug Application for the product without data from further clinical studies.

The FDA said that the nonsteroidal anti-inflammatory drug (NSAID), which is being developed for the relief of the signs and symptoms of osteoarthritis, needs to be tested in one or more additional long-term clinical studies focused on cardiovascular and gastrointestinal safety. Naproxcinod is a version of the popular NSAID naproxen formulated with a nitroxybutyl ester intended to improve the drug's safety profile by allowing it to act as a nitric oxide donor.

The FDA also recommended additional research to establish a meaningful therapeutic benefit attributable to the nitric oxide donation, although no additional clinical efficacy studies were requested.

If naproxcinod is eventually approved in the US, NicOx intends to market the drug with a partner. The company already has partnerships with Merck and Bausch + Lomb for other drug candidates in its pipeline.

Naproxcinod is also currently under review by the European Medicines Agency (EMA).

22nd July 2010

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