FDA asks NicOx for new naproxcinod trial

The FDA has issued a complete response letter asking NicOx to conduct another clinical trial of naproxcinod, a treatment for osteoarthritis. Earlier, an expert panel had voted 16 to 1 against the drug, saying that the French biotech had not offered solid evidence to prove that its painkiller did not raise blood pressure. Concerned about cardiovascular and gastrointestinal side effects of the drug, the agency has recommended that NicOx conduct one or more long-term controlled...

NicOx delays a PhII as it deals with NSAID setback

With its share price down by half in the week since an FDA panel offered a dour assessment of its pain therapy naproxcinod, France's NicOx today tried to calm investors with a few reassuring words as it delayed the start of a mid-stage trial of another drug prospect while it looks for "alternative funding" to pay for it. NicOx says that it's still confident in the medical value of naproxcinod, an assessment that few people on the FDA panel would likely agree with. By a vote of 16 to 1, the...

NicOx shares dive as experts spurn naproxcinod

NicOx's attempt to get regulators to agree that it has made a safe non-steroidal anti-inflammatory drug ran into a wall of doubt yesterday afternoon as a panel of FDA experts voted 16 to 1 to recommend against an approval. The overwhelming majority agreed with staffers at the FDA who had earlier pointed out that the French biotech had not offered solid evidence to prove that its painkiller naproxcinod did not raise blood pressure. The committee vote spooked the biotech's investors, who...

NicOx shares dive after regulators question naproxcinod’s benefits

FDA staffers gave NicOx's naproxcinod a clean bill of health for safety and efficacy for patients with rheumatoid arthritis, but they raised some serious questions about the relative blood pressure benefits the experimental pain therapy could deliver for patients. And with the French biotech company looking to compete in a crowded field of generics, the documents--undercutting its main claim to blockbuster status--caused a number of analysts and investors to lose heart, sending shares of the...