NicOx has announced that a New Drug Application (NDA) for naproxcinod has been submitted to the FDA, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA).
The NDA file contains data from three large pivotal phase 3 studies, which met their co-primary efficacy endpoints. NicOx plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the EMEA in Q4 2009, said the company.
Naproxcinod is NicOx’ anti- inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators), for which NicOx is seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis.
The phase 3 clinical program for naproxcinod consisted of three pivotal trials that enrolled more than 2,700 patients with OA of the knee and hip, the 301, 302 and 303 studies. All three studies met their standard co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject’s overall rating of the disease status).
Michele Garufi, chairman and CEO of NicOx, said: “The submission of a New Drug Application is a tremendous achievement for any company and represents a particularly important milestone for NicOx. This accomplishment represents another major step in NicOx’ planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialization of naproxcinod. To achieve this key corporate goal, we continue to focus on building NicOx’ future commercial operations in the US.”
Pascal Pfister, chief scientific officer and head of research & development at NicOx, said: “To our knowledge, naproxcinod is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX-2 inhibitors rofecoxib and valdecoxib and we believe it could become an important treatment option for patients with OA. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year.”