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 studies of the painkiller. Regulators also said the company should run other studies to demonstrate that the use of nitric oxide in the naproxcinod benefits patients. No clinical efficacy studies were requested.
The Paris-based company didn't indicate what it would do next, but said in a statement that it will meet with the FDA as soon as possible to discuss further steps for naproxcinod. The drug is still under review in the EU. NicOx had €138.5 million in the bank at the end of March 2010.
- here's the NicOx release
- read the BusinessWeek report