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TrendsRx Alert

®

JUNE 2006

VivitrolTM (naltrexone for extended-release injectable suspension)

DRUG APPROVAL

Vivitrol (naltrexone for extended-release injectable suspension, Alkermes Inc. and Cephalon Inc.) was approved by the U.S. Food and Drug Administration for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Treatment with Vivitrol should be part of a comprehensive management program that includes psychosocial support.1 Vivitrol is the first and only once-monthly injectable medication for alcohol dependence.2 The most common side effects observed in patients treated with Vivitrol in clinical trials were nausea, vomiting, headache, dizziness, fatigue and injection site reactions. Vivitrol is given as a 380 mg once-monthly intramuscular injection.1 Other medications used to treat alcohol dependence include Antabuse® (disulfiram, Odyssey Pharmaceuticals), Campral® (acamprosate, Forest Pharmaceuticals), and naltrexone hydrochloride. All three medications are taken orally 1-3 times daily.3-5

BACKGROUND

Alcohol dependence is a disease that is characterized by cravings, loss of control to limit one's drinking, withdrawal symptoms, and tolerance.6 Currently, an estimated 18.2 million persons over the age of 12 are alcohol dependent or abuse alcohol. Alcohol use can lead to many health problems including liver disease, cancer, high blood pressure, heart disease, psychological disorders, and injury from alcohol-related accidents.7 It is estimated that the economic costs of alcohol abuse is approximately $185 billion per year in the U.S.8

PRICING

Estimated cost per course of therapy per plan participant is $2,800 to $3,500.9

CAREMARK RESPONSE

Caremark recognizes the unique needs of plan participants with alcohol dependence. Caremark recommends for your consideration and at your discretion, the management of this product through Caremark Specialty Pharmacy Services.

CAREMARK CONTACT

References:

For more information, please contact your Caremark account representative or our customer service team at (888) 882-5936.

1. Vivitrol [package insert]. Cambridge, MA: Alkermes Inc; April 2006. 2. Alkermes and Cephalon Receive FDA Approval of Vivitrol for the Treatment of Alcohol Dependence [press release]. Frazer, PA: Cephalon Inc; April 13, 2006. Available at http://phx.corporate-ir.net/phoenix.zhtml?c=81709&p=irol-newsArticle&ID=842799&highlight=. Accessed April 14, 2006. 3. Antabuse [package insert]. Florham Park, NJ: Odyssey Pharmaceuticals; January 2005. 4. Campral [package insert]. St. Louis, MO: Forest Pharmaceuticals; August 2005. 5. Naltrexone hydrochloride [monograph]. USP DI Drug Information;. July 1998. 6. National Institute on Alcohol Abuse and Alcoholism. Alcoholism: Getting the Facts. Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism; 2004. Available at http://pubs.niaaa.nih.gov/publications/GettheFacts_HTML/facts.htm. Accessed May 23, 2006. 7. Substance Abuse and Mental Health Services Administration. The National Survey on Drug Use and Health Report. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2006. Available at http://oas.samhsa.gov/2k6/AlcDepend/AlcDepend.pdf. Accessed May 23, 2006. 8. National Institute on Alcohol Abuse and Alcoholism. Updating Estimates of the Economic Costs of Alcohol Abuse in the United States: Estimates, Update Methods, and Data. Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism; 2000. Available at http://pubs.niaaa.nih.gov/publications/economic-2000/index.htm. Accessed May 23, 2006. 9. First Data Bank. June 2006.

©2006 Caremark. All rights reserved.

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