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U.S. Government Organizations Release Positive Information About VIVITROL(R) for the Treatment of Alcoholism

Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism Feature VIVITROL in Recent Publications

FRAZER, Pa. and CAMBRIDGE, Mass., May 15, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- The Substance Abuse and Mental Health Services Administration (SAMHSA), a public health agency within the U.S. Department of Health and Human Services, issued its quarterly Substance Abuse Treatment Advisory developed for the education of healthcare professionals in the field of substance abuse. The advisory features a comprehensive overview of VIVITROL(R) (naltrexone for extended- release injectable suspension), the first and only once-monthly injectable medication for the treatment of alcohol dependence, which was approved by the FDA in April 2006.

This advisory follows the publication of an updated version of Helping Patients Who Drink Too Much: A Clinician's Guide from the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The Guide was recently updated to include information about VIVITROL as the most recently FDA-approved medication for the treatment of alcohol dependence.

"We are pleased that these government organizations have formally recognized VIVITROL, the first and only once-monthly injectable medication for the treatment of alcohol dependence, as an important and effective treatment option in their recent publications," said David Gastfriend, MD, Vice President, Medical Affairs at Alkermes. "We encourage healthcare providers, including addiction specialists and primary care doctors, to utilize this valuable information as they evaluate and treat their patients who struggle with the deadly disease of alcoholism."


The Spring 2007 issue of the SAMHSA Substance Abuse Treatment Advisory features information about VIVITROL including efficacy, safety and patient adherence information. It also includes guidance for healthcare professionals on administration of VIVITROL and tips on how to educate patients about treatment with VIVITROL. To obtain a free copy of the advisory entitled "Naltrexone for Extended-Release Injectable Suspension Treatment of Alcohol Dependence" please visit: or call 1-800-729-6686.

The NIAAA publication Helping Patients Who Drink Too Much: A Clinician's Guide was developed by the NIAAA with the guidance of physicians, nurses, physician assistants and clinical researchers for a wide audience, which includes mental health as well as primary care practitioners, to educate them about how to effectively manage and treat patients with alcoholism. The Guide now includes an updated medications chart and information about each FDA- approved medication for the treatment of alcohol dependence, including VIVITROL. The Guide is available on the NIAAA website,


VIVITROL is a once-monthly, single dose 380 mg intramuscular gluteal injection indicated for patients who are able to abstain from drinking alcohol in an outpatient setting and who are not actively drinking prior to treatment initiation. VIVITROL should be used as part of a comprehensive management program that includes ongoing counseling or group therapy.

VIVITROL, a long-acting form of naltrexone, is effective and generally well tolerated for the treatment of alcohol dependence. In clinical trials, when used in combination with psychosocial support, VIVITROL was shown to reduce the number of drinking days and heavy drinking days and to prolong and maintain abstinence in patients who abstained from alcohol the week prior to starting treatment.

The proprietary Medisorb(R) drug delivery technology utilized in VIVITROL allows the medication to be gradually released into the body at a controlled rate over a one-month time period, providing patients with convenient monthly dosing, which alleviates the need for patients to make daily medication decisions.

VIVITROL is non-addictive - patients did not develop a tolerance for or dependence on VIVITROL. VIVITROL is non-aversive, meaning patients do not become ill as a result of drinking alcohol while on VIVITROL.

VIVITROL should be administered by a healthcare provider. Ongoing interactions with healthcare professionals strengthen the therapeutic alliance and collaborative relationship healthcare professionals form with patients, which is an important component in the recovery process.

VIVITROL works by binding to opioid receptors in the brain. Although the mechanism responsible for reduction in alcohol consumption is not entirely understood, preclinical data suggest that occupation of the opioid receptors by VIVITROL may result in the blockade of the neurotransmitters in the brain believed to be involved with the pleasurable and rewarding effects of alcohol. This blockade may result in the reduction in alcohol consumption observed in patients treated with VIVITROL.

For more information about VIVITROL, please visit or call 1-800-VIVITROL (1-800-848-4876).

Important safety information

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

VIVITROL is contraindicated in patients receiving or dependent on opioids, in acute opioid withdrawal, and in those who have failed the naloxone challenge test or have a positive urine screen for opioids; and in those with previous hypersensitivity to naltrexone, PLG, carboxymethylcelluose, or any other components of the diluent.

Patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in fatal overdose because patients may be more sensitive to lower doses of opioids. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Injection site reactions not improving may require prompt medical attention. Alcohol-dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thinking. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

The most common adverse events associated with VIVITROL in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions and injection site reactions. For full prescribing information, please visit or call 1-800-896-5855.

About Cephalon and Alkermes

Through their corporate joint collaboration, Cephalon, Inc. (Nasdaq: CEPH) an international biopharmaceutical company, and Alkermes, Inc. (Nasdaq: ALKS), a biotechnology company, have made available VIVITROL(R) the most recently FDA-approved medication for the treatment of alcohol dependence. VIVITROL was developed and is manufactured by Alkermes and is marketed by Cephalon. For more information about Cephalon and Alkermes. please visit: or

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the utilization of the SAMHSA and NIAAA publications by healthcare providers. Although the companies believe that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the companies' businesses are subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations.

These risks and uncertainties include whether healthcare providers, including addiction specialists and primary care doctors, utilize the information found in the SAMHSA and NIAAA publications. For further information with respect to factors that could cause the companies' actual results to differ from expectations, reference is made to the respective reports filed by each company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and each of Cephalon and Alkermes disclaim any intention or responsibility for updating such statements, except as may be required by law.

VIVITROL(R) is a registered trademark of Cephalon, Inc.

Medisorb(R) is a registered trademark of Alkermes, Inc.

SOURCE Cephalon, Inc.; Alkermes, Inc.

Corporate-Media Contact: Karen Boyce McCollum of Cephalon, Inc.
Corporate Contact: Rebecca Peterson of Alkermes, Inc.