Both a 750mg dose and 375mg dose of naproxcinod were evaluated in the study. Both were shown to be superior to placebo on all three efficacy endpoints of the study. Blood pressure data for both naproxcinod doses showed a sustained reduction versus baseline and naproxen, confirming earlier published clinical data. Naproxcinod is the first compound in the COX-inhibiting nitric oxide-donating class.
“The positive outcome of this pivotal trial for naproxcinod is an important step towards making this an efficacious and potentially safer treatment option for osteoarthritis patients,” said Thomas Schnitze, professor and assistant dean for Clinical Research at Northwestern University.
Naproxcinod conformed to FDA guidance for demonstrating the efficacy of new drugs for treating the signs and symptoms of osteoarthritis.
Naproxcinod showed good overall safety; 46.7% of the patients treated with naproxcinod 750 mg bid and 40.8% on naproxcinod 375 mg bid experienced at least one adverse event, compared to 56.4% on naproxen 500 mg bid and 38.7% on placebo.
“These data have considerably increased our confidence that we can establish naproxcinod’s non-detrimental blood pressure effect, which will be a key factor in building a blockbuster profile for naproxcinod,” commented Michele Garufi, CEO of NicOx.