FDA AGREES WITH NICOX'S TRIAL PLAN FOR NAPROXCINOD

NicOx announced that the FDA has given the company feedback on the requirements for long-term safety data needed for the submission of a new drug application (NDA) for naproxcinod (HCT 3012). The FDA said that a large safety study would not be required at the time of NDA submission for naproxcinod. The drug is in Phase III clinical development for the treatment of the signs and symptoms of osteoarthritis.

Based on this feedback and previous discussions held with the FDA, NicOx believes that its global registration plan for naproxcinod -- which consists of three Phase III efficacy trials -- will be adequate to satisfy current requirements in the U.S. with regards to demonstrating the efficacy and safety of the drug.

"This response from the FDA confirms that our previously announced clinical plan for naproxcinod will provide an adequate safety database for an NDA submission and is consistent with recent advice received from the [European Medicines Agency]," Philippe Serrano, senior director of regulatory affairs at NicOx, said. "We will continue with our existing clinical plan, with the goal of submitting [applications] for naproxcinod in the U.S. and Europe in the first quarter of 2009."

Last month the European Medicines Agency (EMEA) said it agrees with NicOx's preapproval safety database proposal for naproxcinod. The agency highlighted the importance of the blood pressure monitoring program that NicOx is implementing and stressed the importance of assessing the incidence of new hypertension and hypotension, in addition to platelet function.

Naproxcinod is the first compound in the COX-inhibiting nitric oxide-donating class. The non-steroidal anti-inflammatory drugs (NSAIDs) currently used to treat osteoarthritis have the propensity to increase blood pressure and interfere with antihypertensive medication. The sustained release of nitric oxide from naproxcinod is expected to result in an improved blood pressure profile compared with NSAIDs.