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NicOx to appeal FDA rejection

Tuesday, March 1, 2011 08:30 AM

French biotech NicOx said last week it plans to appeal the FDA’s decision to turn down its anti-inflammatory drug naproxcinod for marketing approval, Reuters reported. NicOx made the announcement at its 2010 earnings presentation.

The agency 2010 refusal to approve naproxcinod, once touted by NicOx as a possible competitor to Pfizer's Celebrex, led NicOx to announce a restructuring of its business, cutting its 128-person workforce in half, shuttering its U.S. headquarters and realigning its R&D efforts.

According to Fierce Biotech, NicOx faces an uphill climb. It never got very far in attempting to persuade U.S. regulators that it had developed a safe, non-steroidal anti-inflammatory painkiller. An expert committee voted 16-to-1 last year that it never made a successful case that the therapy, intended to succeed where Celebrex failed, did not raise blood pressure. The FDA formally agreed soon after, suggesting new clinical studies designed to demonstrate the drug's safety and clinical benefit. Regulators have proved time and again that new drugs intended for mass markets must have clearly defined safety profiles. The chances of the agency changing its decision now would appear to be remote.

In a roundup of events included in the company's annual report, NicOx also reported that preclinical results of a drug for neuropathic pain along with a separate therapy for diabetic macular edema looked promising. And it is currently looking for new alliances for each of the programs.

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