Healthcare Industry News: schizophrenia
News Release - August 17, 2006
Valeant Pharmaceuticals Announces U.S. Availability of Cesamet(TM) (CII) and Initiates Post-Marketing Clinical TrialCOSTA MESA, Calif.--(HSMN NewsFeed)--Aug. 17, 2006--Valeant Pharmaceuticals International (NYSE:VRX ) today announced the availability of Cesamet (CII) (nabilone) oral capsules in U.S. pharmacies nationwide. Valeant received approval for Cesamet, a synthetic cannabinoid, from the Food and Drug Administration (FDA) on May 15, 2006 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments. The Company also announced the initiation of a post-marketing clinical trial in emesis to further explore the patient benefit in using Cesamet to control chemotherapy-induced nausea and vomiting (CINV) and its potential impact on quality of life.
"Cesamet is an important therapy for the 40 to 60 percent 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," said Valeant president and chief executive officer, Timothy C. Tyson. "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 (BID) 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. Throughout the trial, patients will complete a Functional Living Index - Cancer (FLIC) questionnaire and a five day diary to record nausea and pain, use of additional pain medications and adverse events. The International Oncology Network (ION) will oversee the trial.
Important Safety Information
Cesamet, a synthetic cannabinoid similar to the active ingredient found in naturally occurring Cannabis sativa L. (Marijuana; delta-9-tetrahydrocannabainol (delta-9-THC)), is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid. Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet. During controlled clinical trials of Cesamet, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria (feeling "high"), ataxia, headache, and concentration difficulties. Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone. Since Cesamet can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly, and in patients with hypertension or heart disease. Cesamet should also be used with caution in patients with current or previous psychiatric disorders, (including manic depressive illness, depression, and schizophrenia) as the symptoms of these disease states may be unmasked by the use of cannabinoids. Cesamet should be used with caution in individuals receiving concomitant therapy with sedatives, hypnotics, or other psychoactive drugs because of the potential for additive or synergistic CNS effects. Cesamet should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet contains a similar active compound to marijuana. Cesamet should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations. For complete prescribing details, please see full prescribing information. For product-related questions, call Valeant Pharmaceuticals at 1-877-361-2719.
About International Oncology Network (ION)
International Oncology Network (ION) is a diversified physician services company specializing in the support of community-based oncology practices. One function of ION, ION-Clinical Research, supports the critical role played by physicians participating in clinical research while facilitating the needs of a community-based practice setting. By blending innovative strategies and solutions with proven, recognized programs, ION bolsters the quality, effectiveness, and success of its member practices, thereby ensuring that cancer patients receive the most effective treatments available.
Valeant Pharmaceuticals International (NYSE:VRX ) is a global, specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Cesamet is a trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
Source: Valeant Pharmaceuticals
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