FDA Advisory Committee Hears Presentations And Public Comment On EXALGO Extended-Release Tablets

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Sep 2009 - 6:00 PDT

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CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) in a joint meeting of its Anesthetics and Life Support Advisory Committee and its Drug Safety and Risk Management Advisory Committee heard presentations and public testimony and discussed the New Drug Application (NDA) submitted by Neuromed for EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. After hearing presentations, public commentary and asking questions, the joint advisory committee was not asked to vote or make any formal recommendations at the meeting, however the committee did provide feedback to the FDA with regard to the proposed Risk Evaluation and Mitigation Strategy (REMS) program for ExalgoTM. The FDA has assigned a Prescription Drug User Fee Act date of November 22, 2009 to complete its review of the Exalgo NDA.

The U.S. rights to Exalgo™ were acquired by Mallinckrodt Inc., a subsidiary of Covidien on June 11, 2009. CombinatoRx and Neuromed entered into a definitive merger agreement on June 30, 2009 for a merger transaction which is expected to close during the fourth quarter of 2009.

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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