NicOx initiates two ABPM naproxcinod trials

French drug developer NicOx SA has initiated two large clinical pharmacology studies in the USA, which will assess the blood pressure profile of naproxcinod in comparison to ibuprofen and naproxen, using the ambulatory blood pressure monitoring technique. These separate studies, 12 and 16 weeks in duration, will together recruit a total of around 420 osteoarthritis patients with controlled hypertension and results are expected in the fourth quarter.

Naproxcinod is NicOx' lead investigational drug and the first compound in the COX-inhibiting nitric oxide-donating class of anti-inflammatory agents, which is currently in Phase III clinical development for the treatment of the signs and symptoms of osteoarthritis, with results of the last two Phase III studies anticipated in the second half of 2008.

The objectives of these new ABPM studies are to provide additional data on the 24-hour blood pressure profile of naproxcinod in chronically-treated osteoarthritis patients, in comparison to commonly used non-steroidal anti-inflammatory drugs. The French firm hopes that the data will complement the promising results from an earlier two-week ABPM study in healthy volunteers with hypertension.