EMEA AGREES WITH NICOX'S PROPOSED SAFETY DATABASE
NicOx announced it has received scientific advice on its proposed Phase III clinical plan for naproxcinod from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The CHMP stated that it agrees with NicOx's preapproval safety database proposal for naproxcinod, which does not include a long-term cardiovascular safety study, according to the company. NicOx expects to file for marketing authorization for naproxcinod in Europe in the first quarter of 2009.
Naproxcinod is in Phase III development for treating the signs and symptoms of osteoarthritis. Naproxcinod is a unique anti-inflammatory agent and 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. The development program for naproxcinod is designed to demonstrate that the compound has no detrimental effect on blood pressure and good gastrointestinal safety and tolerability.
NicOx will collect safety data during the Phase III trials for naproxcinod, providing a preapproval safety database that satisfies the International Conference on Harmonisation (ICH) E1A recommendations. The company's current plans do not include a separate long-term cardiovascular safety study. The CHMP feedback highlighted the importance of the blood pressure monitoring program that NicOx is implementing in the Phase III program and stressed the importance of assessing the incidence of new hypertension and hypotension, in addition to platelet function.
The CHMP also commented on a number of specific points regarding the assessment of naproxcinod's efficacy in the Phase III trials. NicOx is considering these comments and whether any modifications to the currently proposed design of the trial program should be implemented.
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