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NicOx today announced that the European Medicines Agency (EMEA) has validated the Marketing Authorisation Application (MAA) for naproxcinod, which was submitted through the centralized procedure in December 2009.
NicOx is seeking approval for an indication for the relief of the signs and symptoms of primary osteoarthritis. This follows the acceptance for filing of a New Drug Application (NDA) by the US Food and Drug Administration (FDA) in November 2009.
“The validation of our European application for naproxcinod is a key milestone that follows the acceptance of the NDA for filing in last November,” commented Philippe Serrano, Vice President Regulatory Affairs at NicOx.
“Both the EMEA and the FDA are now reviewing the naproxcinod data and we will be pleased to work together with them throughout this process.”
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.