- VIVITROL Clinical Development Program Expanded with Phase 3b Study in Healthcare Professionals -
CAMBRIDGE, Mass., Apr 21, 2009 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced that it has completed
patient enrollment for the registration study of VIVITROL(R) (naltrexone
for extended-release injectable suspension) for the treatment of opioid
dependence, a chronic brain disease. The data from this study will form
the basis of a supplemental New Drug Application (sNDA) to the U.S. Food
and Drug Administration (FDA) for VIVITROL for this indication. VIVITROL
is a once-monthly, intramuscular injection approved in the U.S. and
Russia for the treatment of alcohol dependence and is not currently
approved for the treatment of opioid dependence. Alkermes expects to
report topline results from this registration study in late calendar
2009 and anticipates a sNDA submission in calendar 2010.
Alkermes also announced today that the company is expanding its VIVITROL
clinical development program for the treatment of opioid dependence and
will initiate a phase 3b study in healthcare professionals, such as
physicians, nurses or pharmacists. The multi-center study will assess
the safety and tolerability of VIVITROL in healthcare professionals with
a history of opioid dependence who are enrolled in an extended
outpatient treatment program that includes psychosocial support, such as
counseling. Data from the study will be used to help further demonstrate
the value of VIVITROL to patients, physicians and payors.
"The completion of patient enrollment in this registration study of
VIVITROL for the treatment of opioid dependence is an important
milestone, as there are few approved medications available for these
patients and no approved long-acting antagonist therapies," stated Dr.
Elliot Ehrich, chief medical officer of Alkermes. "Beyond the
registration study, we are expanding the VIVITROL development program
with a new study of VIVITROL in healthcare professionals. This study
reflects our ongoing commitment to fully elucidate the potential of
VIVITROL in different patient populations and to further evolve the
treatment paradigm for all individuals suffering from opioid dependence.
We very much look forward to the results of both studies."
While opioid dependence affects approximately 1.3 million adults in the
U.S., the rate of prescription opioid misuse is estimated to be five
times higher among physicians than the general population.1,2
Physician impairment is a major public health issue, as it affects not
only these individuals but also their patients, colleagues and families.
For physicians, a long-acting antagonist therapy such as VIVITROL could
be an important treatment option as part of recovery.
"Unfortunately, stressors related to working in healthcare, along with
easier access to opioids, can put healthcare professionals at an
increased risk for addiction to prescription-based therapeutics, such as
pain medications. For the well-being of healthcare professionals and for
the safety of patients, it's important to get healthcare professionals
on the road to recovery," stated Dr. Greg Skipper, medical director,
Alabama Physician Health Program. "A long-acting antagonist therapy,
such as VIVITROL, could provide an important approach to long-term
recovery and potentially help reduce the risk of relapse."
Registration Study Design
The phase 3 randomized, multi-center study is designed to assess the
efficacy and safety of VIVITROL compared to placebo treatment in opioid
dependent subjects who have been recently detoxified and abstinent from
opioids for a minimum of seven days prior to treatment initiation. More
than 250 subjects have been randomized to receive once-monthly
intramuscular injections of either VIVITROL or placebo in combination
with counseling for six months. The primary efficacy endpoint is the
response profile based on the rate of positive urine drug test results.
All participants who complete the randomized portion of the study will
be eligible to continue in an open-label phase and receive VIVITROL once-monthly
in combination with counseling for an additional seven months. The
objective of the extension phase of the study is to assess the long-term
durability of effect, health economics and quality of life outcomes with
once-monthly VIVITROL injections.
Phase 3b Study Design
The phase 3b, open-label, multi-center study will assess the long-term
safety and tolerability of VIVITROL administered to healthcare
professionals with a history of opioid dependence who are actively
enrolled in an extended outpatient treatment program. Approximately 50
subjects will receive once-monthly intramuscular injections of VIVITROL
in combination with psychosocial support for 24 months. The primary
safety endpoint will be measured by the incidence of adverse events. The
efficacy of VIVITROL and its effect on quality of life will also be
About Opioid Dependence
In addition to the use of heroin, an illegal opioid, opioid abuse and
addiction includes the non-medical use of FDA-approved opioid
analgesics, including prescription pain relievers, and represents a
growing public health problem in the U.S. According to the 2006 U.S.
National Survey on Drug Use and Health, an estimated 1.3 million people
aged 18 or older were dependent on or abused pain relievers or heroin.1
Researchers have found that the cost of prescription opioid abuse in the
U.S. in 2001 was $9.2 billion.3
Alkermes, Inc. is a fully integrated biotechnology company committed to
developing innovative medicines to improve patients' lives. Alkermes
developed, manufactures and commercializes VIVITROL(R) for
alcohol dependence and manufactures RISPERDAL(R) CONSTA(R) for
schizophrenia. Alkermes' robust pipeline includes extended-release
injectable, pulmonary and oral products for the treatment of prevalent,
chronic diseases, such as central nervous system disorders, addiction
and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has
research facilities in Massachusetts and a commercial manufacturing
facility in Ohio.
VIVITROL is the first and only once-monthly, extended-release injectable
medication for the treatment of alcohol dependence and was approved by
the U.S. Food and Drug Administration in April 2006. The proprietary
Medisorb(R) drug delivery technology in VIVITROL enables the
medication to be gradually released into the body at a controlled rate
over a one-month time period.
For more information about VIVITROL, please visit 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 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
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
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
or call 1-800-VIVITROL.
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 continued
development of VIVITROL for the treatment of opioid dependence and the
potential therapeutic value of VIVITROL for the treatment of opioid
dependence in healthcare professionals or other individuals. Although
the company believes 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 company's business is 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, among others: whether data from the ongoing
registration study will be sufficient to form the basis of a sNDA for
VIVITROL for the treatment of opioid dependence; the results of the
clinical trial of VIVITROL for the treatment of opioid dependence in
healthcare professionals; decisions by the FDA or foreign regulatory
authorities regarding VIVITROL for the treatment of opioid dependence;
and potential changes in cost, scope and duration of the registration
study and the phase 3b clinical trial of VIVITROL for the treatment of
opioid dependence. For further information with respect to factors that
could cause the company's actual results to differ materially from
expectations, reference is made to the reports the company filed 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 the company disclaims any
intention or responsibility for updating predictions or financial
expectations contained in this release.
VIVITROL(R) is a registered trademark of Alkermes, Inc. and
RISPERDAL(R) CONSTA(R) is a registered trademark of
Janssen-Cilag group of companies.
1 SAMHSA, Office of Applied Studies, National Survey on
Drug Use and Health, 2006 and 2007.
2 Merlo MJ and Gold MS. Prescription Opioid Abuse and
Dependence Among Physicians: Hypotheses and Treatment. Harv Rev
Psychiatry. 2008 16(3):181-94.
3 Birnbaum HG, White AG, Reynolds JL, Greenberg PE,
Zhang M, Vallow S, Schein JR, Katz NP. Estimated costs of
prescription opioid analgesic abuse in the United States in 2001:
A societal perspective. Clin J Pain. 2006 Oct;22(8):667-76.
SOURCE: Alkermes, Inc.
Rebecca Peterson, 617-583-6378
Jennifer Snyder, 617-583-6166