NicOx initiates final Ph III naproxcinod trial

French drugmaker NicOx SA has initiated the third pivotal Phase III trial of naproxcinod in patients with osteoarthritis of the hip. The 303 study is expected to enroll 800 patients at around 100 centers in North America and Europe and is the final Phase III trial in NicOx' plan for filing. The objective of this study is to demonstrate naproxcinod's efficacy in relieving the signs and symptoms of osteoarthritis and provide safety data, primarily to confirm naproxcinod's improved blood pressure profile compared to current treatments. Efficacy results are expected mid-2008.

NicOx aims to develop naproxcinod as the first compound in the COX-inhibiting nitric oxide-donating class for osteoarthritis. The firm believes that naproxcinod has the potential to become the drug of choice for the condition, based on its unique profile that shows no detrimental effects on blood pressure and a good gastrointestinal tolerability. The 303 study will provide the final data for a predefined pooled analysis on the blood pressure measurements from the full Phase III program. Naproxcinod's improved blood pressure profile will be a key differentiating factor in the current anti-inflammatory market, NicOx noted.