Exalgo regulatory update

FDA extended by three months the PDUFA date for an NDA from Neuromed for Exalgo hydromorphone to manage moderate to severe pain in opioid-tolerant patients to Feb. 22 from Nov. 22. According to Neuromed and its U.S. commercialization partner, Covidien, FDA needed more time to complete the review. Neuromed had submitted supplemental information, which the agency considered to be a major amendment.

Earlier in the week, Neuromed said FDA had indicated that the NDA is "not sufficient" for approval in its current form. At that time, the company said that if FDA issues a complete response letter, possible next steps may include submitting additional information to FDA, or resubmitting the NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on the safety and efficacy of previously approved products. In September, a joint FDA panel agreed that Exalgo has a high potential of being misused compared with other opioid drug products and said it should have a more strict risk evaluation and mitigation strategy (REMS) than those for other drugs in its class (see BioCentury, Sept. 28). ...