Naproxcinod, a potential treatment for the signs and symptoms of osteoarthritis, is in the second and largest of three phase III clinical trials, according to FDA News. The three trials are referred to as 301, 302, and 303. Naproxcinod is the first compound in the COX-Inhibiting Nitric Oxide-Donating class of drugs (CINOD) -- a class of drugs designed to have superior cardiovascular safety than COXIBs (COX-2 selective NSAIDs like Celebrex) and cause less gastrointestinal damage than naproxen, one of the older NSAIDs (nonsteroidal anti-inflammatory drugs).
French drugmaker NicOX has enrolled 1,020 study participants in the latest phase III trial (302) at 150 clinical sites in the United States. The 302 study is a randomized, double-blind, efficacy and safety study of patients with osteoarthritis of the knee. Patients have been randomly assigned to receive naproxcinod 375 mg/twice a day/for 52 weeks, naproxcinod 750 mg/twice a day/for 52 weeks, naproxen 500 mg/twice a day/for 52 weeks, or placebo twice a day for the first 13 weeks.
The first Phase III trial (301) demonstrated a similar effect on blood pressure compared to placebo and a similar effect on reducing inflammation compared to naproxen. The third Phase III trial (303) is a 13 week trial of patients with osteoarthritis of the hip. NicOx plans to file for U.S. FDA approval for naproxcinod in mid-2009.
Related Resources:
- Osteoarthritis Medications
- Treatment of Osteoarthritis
- Does Inflammation Play a Role in Osteoarthritis?
Photo by tdenham (stock.xchng)
