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Valeant announces U.S. availability of Cesamet; post-marketing clinical trial to start soon
By Elaine Rigoli
Tampa, Fla., Aug. 17 - Valeant Pharmaceuticals International said Cesamet (CII) (nabilone) oral capsules are now available in U.S. pharmacies nationwide and said it will start a post-marketing clinical trial to explore the benefit in using Cesamet to control chemotherapy-induced nausea and vomiting and its potential impact on quality of life.
"Cesamet is an important therapy for the 40% to 60% of cancer chemotherapy patients who continue to experience nausea and vomiting despite the use of conventional anti-emetic treatments. With the availability of Cesamet, patients and their caregivers have an alternative treatment option to help reduce these debilitating symptoms," president and chief executive officer Timothy C. Tyson said in a company news release.
"We are looking forward to initiating a post-marketing trial with Cesamet and remain committed to continued research in supportive care."
A multi-center, open-label, sequential treatment study will evaluate over two chemotherapy cycles the safety and tolerability of Cesamet 2 mg twice-daily in 40 patients who are receiving standard chemotherapy for the treatment of non-small cell lung cancer, breast cancer or colorectal cancer, and have failed to respond adequately to standard anti-emetic regimens.
As secondary endpoints, the trial will evaluate the possible incremental benefit of adding Cesamet to standard anti-emetic regimens to decrease pain and analgesic use, and the potential improvement in global quality of life, the release said.
Valeant is a specialty pharmaceutical company based in Costa Mesa, Calif.
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