NicOx submits naproxcinod MAA to the EMEA
Naproxcinod is NicOx’s lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators). The MAA file is supported by data from a large program of 34 clinical trials that involved more than 4,000 subjects treated with naproxcinod. The program evaluated the efficacy of naproxcinod in relieving signs and symptoms of osteoarthritis, as well as its safety, with a particular care given to its effect on blood pressure.
Philippe Serrano, Vice President Regulatory Affairs at NicOx, commented: “As planned, we have ended 2009 with the regulatory submissions for naproxcinod both in Europe, where we have just submitted an MAA through the centralized procedure, as well as the United States, where the FDA has recently accepted our NDA for filing.”
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