NicOx Reports on Naproxcinod's Phase III Development
French drugmaker NicOx has enrolled 1,020 patients in a Phase III study for naproxcinod, a treatment for treating the signs and symptoms of osteoarthritis.
The 302 study is the largest of the three Phase III trials for naproxcinod.
In the 301 study, naproxcinod met all three primary efficacy endpoints and demonstrated a similar effect on systolic blood pressure as placebo and a similar inflammation reduction compared with naproxen, a commonly used anti-inflammatory, NiOx said.
The 303 study is a 13-week trial in patients with osteoarthritis of the hip that began in June. The 303 study should complete enrollment in the second quarter of 2008.
The company anticipates filing of a new drug application for naproxcinod with the FDA in mid-2009.