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 panel maintained that NicOx never made its case that its nitric-oxide-releasing approach made this NSAID pain drug any safer than the other NSAIDs that have already been on the market. And another NSAID therapy with the same health benefits as its competitors with no improvement in risk has little value--certainly nothing like the blockbuster potential that NicOx had claimed.

NicOx CEO Michele Garufi continues to insist that the developer will pursue new talks with the FDA as it seeks approval. But today the program for NCX 6560 will be at least temporarily put on the back shelf as the developer seeks "alternative funding options to develop NCX 6560 which will conserve NicOx's capital." The French biotech, meanwhile, is pursuing discussions with European regulators as well, where it also hopes to score an approval.

- see the NicOx release
- read the story from Dow Jones

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