Valeant Pharmaceuticals (VRX) Files IND with FDA for Cesamet
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Valeant Pharmaceuticals International (NYSE: VRX) has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Cesamet(R) (CII) (nabilone) oral capsules for the treatment of cancer chemotherapy-induced neuropathic pain. Cesamet, a synthetic cannabinoid, was launched by Valeant in the United States in 2006 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Cesamet was recently approved in Mexico for the treatment of chemotherapy-induced nausea and vomiting and pain.
A report from the Institute of Medicine (IOM) regarding the treatment of chronic pain concluded that a cannabinoid could potentially be useful for chemotherapy patients and those with peripheral neuropathic pain.
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