Salix Pharmaceuticals, Ltd. (SLXP) Release: FDA Ad Comm Provides Recommendations Regarding The Potential Cardiovascular Risk Associated With The Class Of Peripherally-Active Opioid Receptor Antagonists And The Trials To Support Approval Of Products For OIC
6/13/2014 8:08:46 AM
RALEIGH, N.C. & TARRYTOWN, N.Y.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today reported that the Anesthetic and Analgesic Drug Products Advisory Committee of the Food and Drug Administration (FDA) has provided an assessment of potential cardiovascular risk associated with products in the class of peripherally-active opioid receptor antagonists (PAMORAS) and recommendations regarding the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in this class for the proposed indication of opioid-induced constipation (OIC) in patients taking opioids for chronic pain.
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