CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed’s submission, including a recent amendment by Neuromed to the Exalgo NDA.
Neuromed will continue to work with Mallinckrodt Inc., who owns the commercial rights to Exalgo, to obtain FDA approval of the Exalgo NDA under Section 505(b)(1) of the Food Drug and Cosmetic Act of 1938, as amended (FDCA). Neuromed and Mallinckrodt may be successful in these efforts and the FDA may approve the Exalgo NDA in its current form on or before the new PDUFA date. However, the Exalgo NDA in its current form may not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the FDCA. If that is the case, the FDA may issue a complete response letter to Neuromed, and Neuromed and Mallinckrodt may choose to provide additional data or information to provide a basis for approval of Exalgo or may resubmit the Exalgo NDA under Section 505(b)(2) of the FDCA. At this time, the outcome of any of these efforts or actions is not certain.