The FDA wants more time to review the NDA for Exalgo, a pain drug to be sold by Mallinckrodt, and has extended the Prescription Drug User Fee Act date three months to Feb. 22, 2010. The FDA's decision comes after more information was submitted to the NDA.
Neuromed Pharmaceuticals, which sold the rights to the drug to Mallinckrodt in June, will work with Mallinckrodt to obtain FDA approval for Exalgo (hydromorphone HCl), according to the CombinatoRx statement. Neuromed merged with CombinatoRx in July.
Representatives from Mallinckrodt and Neuromed appeared before joint meeting of the FDA's Anesthetics and Life Support and Drug Safety and Risk Management Advisory Committees in September to solicit feedback with regard to the proposed Risk Evaluation and Mitigation Strategy program for Exalgo.
The benefit of Exalgo is that sufferers won't have to take the drug as often as other treatments already on the market. But FDA staff reviewers have expressed concern about the drug's potential for abuse, noting that it can easily be crushed. At the September meeting, the committees expressed approval for the companies' proposed REMS, called the Exalgo Alliance, which combines education, controlled access and ongoing surveillance.
- read the CombinatoRx release