Published on September 23, 2009 at 3:02 AM
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 posted on its website briefing documents for the September 23, 2009 joint meeting of its Anesthetics and Life Support Advisory Committee and its Drug Safety and Risk Management Advisory Committee. At the meeting, the committees will review and discuss Neuromed’s New Drug Application (NDA) for Exalgo™ (hydromorphone HCI 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.
Briefing documents from FDA and Neuromed can be found on FDA’s website at: http://www.fda.gov/AdvisoryCommittees.
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.
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