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Biopharmaceuticals FDA

 News Release - February 22, 2007

Valeant Pharmaceuticals Files Investigational New Drug Application for Cesamet(R) in Cancer Chemotherapy-Induced Neuropathic Pain

ALISO VIEJO, Calif.--(HSMN NewsFeed)--Valeant Pharmaceuticals International (NYSE:VRX ) today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Cesamet® (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.

"The filing of our IND is a significant milestone in the development of Cesamet. There are more than 150,000 new cases of chemotherapy-induced neuropathic pain per year in the United States, with no current approved therapy for these patients. The development of a new agent to control chemotherapy-induced neuropathic pain would fulfill a significant unmet need for patients and physicians to treat the symptoms from chemotherapy-induced neuropathic pain," said Wes Wheeler, President, Valeant North America/Research and Development.

"It is exciting that Valeant is initiating this trial to determine whether Cesamet's unique effect on cannabinoid receptors found throughout the body could play a role in treating chemotherapy-induced neuropathic pain," said Joseph Pergolizzi, M.D., adjunct assistant professor, Johns Hopkins University School of Medicine. "Cesamet has proven to be an effective tool for those who have not responded well to conventional antiemetic treatment for chemotherapy-induced nausea and vomiting."

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. In its report, the IOM also noted that clinical studies of cannabinoids should be prioritized.

Although there are currently no approved treatments for chemotherapy-induced neuropathic pain, treatments for other types of neuropathy include opioids, tricyclic antidepressants, GABA analogs and nonsteroidal anti-inflammatory drugs. According to an article in the journal PAIN, the treatment of neuropathic pain is still difficult despite new therapies, and there is no single therapy that works for all conditions and their underlying mechanisms.

Chemotherapy-Induced Neuropathic Pain Background

Chemotherapy-induced neuropathic pain can be caused by certain chemotherapy drugs, including taxanes, vinca-alkaloids and platinum-derived treatments. The onset of chemotherapy-induced neuropathic pain is generally early in treatment, between the first and third cycle, with the peak in severity occurring approximately three months into therapy. Incidence and severity depend on a variety of factors including type of chemotherapy and dose. For example, neuropathy occurs in approximately 45 percent to 50 percent of ovarian cancer patients receiving cisplatin alone, but this increases to a frequency of 90 percent to 100 percent when cisplatin is administered along with paclitaxel.

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 by visiting www.cesamet.com. For product-related questions, call Valeant Pharmaceuticals at 1-877-361-2719.

About Valeant

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 registered 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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