NicOx S.A today announced that it has received scientific advice on its proposed phase 3 clinical plan for naproxcinod (HCT 3012) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
The CHMP stated that it agrees with NicOx' pre-approval safety database proposal for naproxcinod, which does not include a long-term cardiovascular safety study. NicOx expects to file a Marketing Authorization Application (MAA) for naproxcinod in Europe during the first quarter of 2009.
Philippe Serrano, Senior Director of Regulatory Affairs at NicOx, commented: "We are very pleased that the European Medicines Agency agrees with our proposed pre-approval safety database for naproxcinod, which conforms with ICH guidelines. We view this as a significant step toward the commercialization of this potentially important treatment option for patients suffering from osteoarthritis."
Naproxcinod, NicOx' most advanced product, is in phase 3 development for treating the signs and symptoms of osteoarthritis. Naproxcinod is a unique anti-inflammatory agent and the first compound in the CINOD (COX-inhibiting nitric oxide-donating) class. The development program for naproxcinod is designed to demonstrate that the compound has no detrimental effect on blood pressure and good gastroint estinal safety and tolerability. NicOx aims to establish naproxcinod as the drug-of-choice for osteoarthritis patients.
In the scientific advice provided to NicOx, the CHMP stated that it agrees with the Company's safety database proposal for naproxcinod. NicOx will collect safety data during the phase 3 trials for naproxcinod (see NOTE 1), providing a preapproval safety database that satisfies the International Conference on Harmonization (ICH) E1A recommendations.
NicOx' current plans do not include a separate long-term cardiovascular safety study.