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NicOx S.A. says Third Pivotal Phase 3 Study for Naproxcinod Shows Positive Efficacy, Safety and Blood Pressure Results - Quick Facts

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

NicOx S.A. (COX) announced that the third pivotal phase 3 study for naproxcinod in patients with OA of the hip showed a highly statistically significant result on all three co-primary efficacy endpoints of the trial.

Naproxcinod 750 mg bid showed the same gastrointestinal (GI) adverse event rate and a similar blood pressure profile to placebo.

Naproxcinod is the most advanced compound in a novel class of anti-inflammatory agents known as Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs).

Following the positive results from the 301 and 302 studies in patients with OA of the knee, 303 represents the third phase 3 study for naproxcinod to achieve p<0.001 on all three co-primary efficacy endpoints.

The 303 study is also the final pivotal trial that NicOx plans to include in the submission of a New Drug Application to the US Food and Drug Administration in mid-2009.

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