NicOx Presents 26week Naproxcinod Efficacy Data at American College of Rheumatology
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NicOx S.A. has announced the presentation of detailed 26week efficacy, safety and tolerability data from the second pivotal phase 3 study for naproxcinod (the 302 study) yesterday, at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.
It was entitled ‘26-Week Efficacy and Safety Evaluation of Naproxcinod, a First-in-Class Cyclooxygenase Inhibiting Nitric Oxide Donator (CINOD), in Patients with Osteoarthritis of the Knee.’
The presentation was based on data from 1011 knee-OA patients enrolled in the 302 study, who were randomized to receive naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 500 mg bid or placebo bid. After 13 weeks, patients randomized to placebo received naproxcinod 375 or 750 mg bid.
After 26 weeks of treatment, naproxcinod 750 mg bid was non-inferior to naproxen 500 mg bid on the WOMAC™ pain and function subscales. Noninferiority comparisons to existing products are required by the European Medicines Agency (EMEA) for demonstrating the efficacy of new drugs.
NicOx has submitted a New Drug Application (NDA) for naproxcinod to the United States Food and Drug Administration (FDA) on September 24th, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis, and plans to submit a Marketing Authorization Application (MAA) to the EMEA in Q4 2009.
It was entitled ‘26-Week Efficacy and Safety Evaluation of Naproxcinod, a First-in-Class Cyclooxygenase Inhibiting Nitric Oxide Donator (CINOD), in Patients with Osteoarthritis of the Knee.’
The presentation was based on data from 1011 knee-OA patients enrolled in the 302 study, who were randomized to receive naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 500 mg bid or placebo bid. After 13 weeks, patients randomized to placebo received naproxcinod 375 or 750 mg bid.
After 26 weeks of treatment, naproxcinod 750 mg bid was non-inferior to naproxen 500 mg bid on the WOMAC™ pain and function subscales. Noninferiority comparisons to existing products are required by the European Medicines Agency (EMEA) for demonstrating the efficacy of new drugs.
NicOx has submitted a New Drug Application (NDA) for naproxcinod to the United States Food and Drug Administration (FDA) on September 24th, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis, and plans to submit a Marketing Authorization Application (MAA) to the EMEA in Q4 2009.
