Acura Pharmaceuticals and King Pharmaceuticals, partners on drug Acurox, may be able to get the pain drug through an FDA review without more clinical data. After a meeting on Wednesday, the companies said the FDA will not require new clinical trials for the drug at this time.
Acurox is a single-dose tablet containing opiate oxycodone and niacin. The drug also utilizes a proprietary technology designed to deter abuse of the drug, which has not been clinically tested, RTTNews report. The drugmakers expected a decision from the FDA in late June. Instead the agency issued a complete response letter, citing concerns about Acurox's potential abuse-deterrent benefits. The two companies said in July that they could address those questions without conducting additional studies.
Acura and King have agreed to meet with an advisory committee to evaluate the drug. The FDA did not give drugmakers a date for the panel's review, but the companies said they do not expect the meeting to take place this year.