US FDA's Complete Response Letter to NicOx' NDA for naproxcinod calls for more studies
France's NicOx says it has received a Complete Response Letter from the US Food and Drug Administration related to the New Drug Application for naproxcinod, which 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 agency 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.
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