NicOx S.A. has met with the United States Food and Drug Administration (FDA) to discuss the proposed use of naproxcinod 375 mg twice daily (bid), for the treatment of signs and symptoms of osteoarthritis (OA) of the knee, under a proposed new drug application (NDA) that would require additional clinical data prior submission.
The subject of the meeting was the required clinical data for the potential new NDA for naproxcinod 375 mg bid.
NicOx will assess the requirements for further clinical data discussed with the FDA and its impact on the overall development program of naproxcinod.
NicOx intends to seek a partner to fund and manage any further development and potential commercialisation of naproxcinod.
NicOx had previously submitted an NDA for naproxcinod 375 mg bid and 750 mg bid for the treatment of signs and symptoms of OA not limited to the knee.
NicOx received a Complete Response Letter in July 2010 stating that the FDA did not approve that naproxcinod NDA.
NicOx initiated a Formal Dispute Resolution process in July 2011 regarding that decision surrounding the previously submitted NDA.