Pubdate: Tue, 17 May 2005 Source: Medical Post (Canada) Copyright: 2005 The Medical Post Contact: http://www.medicalpost.com/ Details: http://www.mapinc.org/media/3180 Author: Laura Common Bookmark: http://www.mapinc.org/find?232 (Chronic Pain) Bookmark: http://www.mapinc.org/topics/Sativex (Sativex) NEW DRUG UPDATE Cannabis-Based Spray Relieves MS New Product Sativex Spray Use: multiple sclerosis (MS) Health Canada has approved Sativex (Cannabis sativa L. extract), an oral spray developed for the symptomatic relief of neuropathic pain in adults with MS. Sativex is a novel medication derived from the cannabis plant. Fifty per cent of MS patients suffer from chronic neuropathic pain, according to estimates and respond inadequately to current treatment options that control their pain. A double-blind placebo-controlled study showed Sativex provided significantly greater pain relief than placebo and reduced pain-related sleep disturbance. A standardized dose of the drug's active cannabinoid components is delivered each time Sativex is used. Resulting from research efforts in the U.K., Sativex is marketed in Canada by Bayer HealthCare, Pharmaceuticals Division. Sativex is the world's first cannabis-based analgesic. New Indications Femara tablets Use: breast cancer Health Canada has approved Femara (letrozole) to treat hormone-receptor positive early breast cancer in postmenopausal women who have previously received standard tamoxifen therapy for five years. For these patients, letrozole has been shown to reduce the risks of breast cancer recurrence and of metastases. In the U.S., the FDA has already approved Femara for this indication (in October 2004) and the new indication is also approved in the U.K., Switzerland and other countries. More than 100,000 breast cancer survivors in North America complete tamoxifen therapy each year. While tamoxifen benefits these patients for five years, after that time its risks exceed its benefits. Letrozole is an oral, once-daily non-steroidal aromatase inhibitor. Evidence of the efficacy of the drug as extended adjuvant treatment was provided by trials comprising one of the largest ever evaluations of an aromatase inhibitor in an adjuvant setting. The evaluations involved nearly 13,000 postmenopausal women. The results of a major Canadian-led study of Femara, the MA-17 study, were published in the New England Journal of Medicine in November 2003 and presented at the American Society of Clinical Oncology meeting in June 2004. In the MA-17 trial, the effectiveness of Femara proved to be so profound that an independent committee recommended that the researchers disclose the results early, so women receiving placebo could receive Femara. Although the intended duration of extended adjuvant therapy with Femara is five years, data on efficacy endpoints is limited to a median followup of 28 months. The clinical evidence collected to date demonstrates a statistically significant increase in disease-free survival but no overall survival advantage has been consistently demonstrated. Femara is also indicated for the hormonal treatment of advanced/metastatic breast cancer in women with natural or artificially induced postmenopausal status, who have disease progression following antiestrogen therapy. Letrozole is supplied in Canada by Novartis Pharmaceuticals Canada Inc. In 2001, Health Canada approved the drug as first-line treatment of advanced breast cancer in postmenopausal women. Fragmin Solution Use: thrombosis Pfizer Canada Inc., maker of the anticoagulant Fragmin (dalteparin), announced it has been approved to prevent the recurrence of venous thromboembolism in patients with cancer. This common complication in patients with malignant disease is the second leading cause of death in cancer patients, after death from the cancer itself. One multinational Canadian-led randomized trial suggested that dalteparin surpasses warfarin in the long-term treatment of venous thromboembolism (VTE) in cancer patients. The cumulative rate of recurrent VTE events over a six-month period was reduced from 17.4% in the warfarin group to 8.8% in the Fragmin group. Risperdal, Risperdal M tablets,/B) Use: antipsychotic agent Risperdal (risperidone), from Janssen-Ortho Inc., is now indicated as monotherapy for the management of acute episodes of mania associated with bipolar 1 disorder. Three placebo controlled trials, each three-weeks in duration, have established the efficacy of risperidone in the treatment of acute bipolar mania. Risperidone's safety and effectiveness however, for long-term use and for prophylactic use in bipolar patients, have not been evaluated. Physicians who elect to use risperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for each individual patient. Topamax tablets and capsules Use: epilepsy The anticonvulsant Topamax (topiramate) is now indicated as monotherapy for the management of patients (adults and children six years and older) with newly diagnosed epilepsy. Topiramate has already been approved in more than 60 countries as monotherapy for epileptic seizures. Topiramate is also indicated as adjunctive therapy for the management of patients (adults and children two years and older) with epilepsy who are not satisfactory controlled with conventional therapy. The supplier of Topamax is Janssen-Ortho Inc. Product Monograph Revisions Health Canada has announced product monograph revisions for the following: Crestor (rosuvastatin), the lipid metabolism regulator from AstraZeneca Canada Inc. Lovenox (enoxaparin), the anticoagulant from Aventis Pharma Inc. Avandia (rosiglitazone), the insulin resistance reducing agent from GlaxoSmithKline Inc. Avodart (dutasteride), the 5 alpha reductase inhibitor for benign prostatic hyperplasia, from GlaxoSmithKline Inc. - --- MAP posted-by: Beth