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."
ABOUT THE PUBLICATIONS
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:
http://www.kap.samhsa.gov/products/manuals/advisory/index.htm or call
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
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
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 http://www.vivitrol.com
or call 1-800-VIVITROL (1-800-848-4876).
Important safety information
Naltrexone has the capacity to cause hepatocellular injury when given in
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
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
http://www.vivitrol.com 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:
http://www.cephalon.com or http://www.alkermes.com.
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.