SOPHIA ANTIPOLIS, France—NicOx SA has filed a New Drug Application (NDA) for the first in a new class of anti-inflammatory agents, the CINODs (cyclooxygenase-inhibiting nitric oxide donators). The new drug, naproxcinod, is intended for the relief of the signs and symptoms of osteoarthritis (OA).

NicOx also expected to seek European approval for Naproxcinod

The NDA request is based on data from three large pivotal phase 3 studies in more than 2700 patients with knee or hip OA. All 3 studies met their co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of the disease status). The company plans also to seek European Medicines Agency (EMEA) approval in Q4 2009.

Michele Garufi, Chairman and CEO of NicOx, declared, "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's 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's future commercial operations in the US."

No untoward blood pressure effects seen with naproxcinod

The phase 3 assessments of naproxcinod's blood pressure profile, as well as 3 randomized, controlled clinical pharmacology studies in a total of 548 subjects, all found that the drug was well tolerated.

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 would like to congratulate our whole Research & Development department on the submission of this high quality NDA, which includes extensive data on naproxcinod's efficacy, safety and tolerability, collected in more than 4,000 patients. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year."