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Home » VALEANT TO LAUNCH POSTMARKETING STUDY OF CESAMET
VALEANT TO LAUNCH POSTMARKETING STUDY OF CESAMET
August 18, 2006
Valeant Pharmaceuticals International has announced the availability of Cesamet (nabilone) oral capsules in U.S. pharmacies. The FDA approved the drug, a synthetic cannabinoid, in May for the treatment of nausea and vomiting associated with chemotherapy in cancer patients who have failed to respond adequately to conventional anti-emetic treatments.
The company also announced the initiation of a postmarketing clinical trial in emesis to further explore the patient benefit of using Cesamet to control chemotherapy-induced nausea and vomiting and its impact on the quality of life.
A multicenter, open-label, sequential treatment trial will evaluate 40 patients over two chemotherapy cycles to assess the safety and tolerability of Cesamet 2 mg twice-daily. The study will enroll patients who are receiving standard chemotherapy for the treatment of non-small-cell lung cancer, breast cancer or colorectal cancer, and who have failed to respond adequately to standard anti-emetic regimens. As a secondary endpoint, the trial will evaluate the possible incremental benefit of adding Cesamet to standard anti-emetic regimens to decrease pain and analgesic use.
KEYWORDS Drug Pipeline Alert
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