FDA Extends NDA Review For Exalgo™ Extended-Release Tablets

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Nov 2009 - 4:00 PDT

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CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, 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.

The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009. Under the agreements between Neuromed and Mallinckrodt, Neuromed has received milestone payments totaling $15 million, and if Exalgo is approved by the FDA, Neuromed is eligible to a milestone payment of $30 million, which could potentially increase to $40 million. Mallinckrodt has also agreed to fund certain clinical development and regulatory activities of Neuromed, up to a cap of $16 million.

About CombinatoRx

CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action, striking at the biological complexities of human disease. The CombinatoRx proprietary drug discovery technology provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts. To learn more about CombinatoRx, please visit http://www.combinatorx.com.

Source
Neuromed

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