NicOx Submits Naproxcinod for the Relief of Osteoarthritis to EMEA

[bianca dellepiane]

NicOx S.A. announced that a Marketing Authorization Application (MAA) for naproxcinod has been submitted to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in September that has recently been accepted for filing.

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.

For further information: www.nicox.com

Source: ASSOBIOTEC