PARIS, July 22 (Reuters) – The U.S. Food and Drug Administration has rejected NicOx’s (NCOX.PA) pain drug Naproxcinod, recommending further trials, the French biotechnology group said on Thursday.
NicOx, which has spent about 10 years and 100 million euros ($127.6 million) to fund the U.S. launch of its lead anti-inflammatory drug, said it would hold talks with the FDA as soon as possible to discuss potential next steps.
Citing a response letter, NicOx said the FDA had recommended conducting more long-term controlled studies to assess the safety of Naproxcinod on a cardiovascular and gastrointestinal level.
An FDA advisory panel had already voted against approving the drug in May, sending NicOx shares to a four-year low. [ID:nLDE64C05Z]
NicOx Chief Executive Michele Garufi told Reuters last month he remained hopeful for the drug, even as some analysts questioned the group’s drug development technology. [ID:nLDE65F295] (Reporting by Lionel Laurent and James Regan; Editing by David Holmes) ($1=.7836 Euro)