NicOx SA announced that a New Drug Application (NDA) for naproxcinod has been submitted to the United States Food and Drug Administration (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, all of which met their co-primary efficacy endpoints. NicOx plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) 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' 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."
Naproxcinod is NicOx' lead compound and the first in a new class of 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 programme for naproxcinod consisted of three large 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 three standard coprimary efficacy endpoints (the Womac pain subscale, the Womac function subscale and subject's overall rating of the disease status). The phase-3 programme also specifically assessed naproxcinod's blood pressure profile, through the collection of Office Blood Pressure Measurements (OBPMs) in a rigorous and standardized manner as a pre-specified secondary endpoint. Moreover, NicOx conducted three randomized, controlled clinical pharmacology studies in a total of 548 subjects, which were specifically designed to characterize naproxcinod's 24-hour blood pressure profile using Ambulatory Blood Pressure Monitoring (ABPM).
The safety database for the naproxcinod NDA submission includes over 6,700 patients, of which more than 4,000 were exposed to naproxcinod. NicOx believes that the data from the clinical studies for naproxcinod show that it is effective, safe and well tolerated.
Pascal Pfister, chief scientific officer and head of Research & Development at NicOx, added, "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."