NicOx plans long-shot appeal of FDA's naproxcinod rejection

The FDA's decision to reject NicOx's naproxcinod last year forced the French biotech to cut its 128-person workforce in half, shutter its U.S. headquarters and realign its R&D efforts. And now Reuters is reporting that the biotech plans to head back to the agency and appeal the decision.

The biotech faces an uphill climb. NicOx 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 the developer never made a successful case that the therapy, intended to succeed where Celebrex failed, did not raise blood pressure. The agency formally agreed soon after, suggesting new clinical studies designed to demonstrate the drug's safety and clinical benefit. And in the meantime, regulators have proved time and again that new drugs intended for mass markets have to 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 for a drug for neuropathic pain along with a separate therapy for diabetic macular edema looked promising. And the developer said that it is currently in the hunt for new alliances on each of the programs.

- read the company release
- see the Reuters story