–– Investigator-Led Study Showed Treatment With
Extended-Release Naltrexone Reduced Relapse Rates and Demonstrated
Longer Median Time to Relapse to Opioid Dependence During Six-Month
Treatment Period ––
–– Current VIVITROL® Use in Criminal Justice
Setting Highlights Importance of Medication Along With Continuity
of Care, Including Community-Based Addiction Recovery Support
––
Results from a study published this week in the New England
Journal of Medicine (NEJM) demonstrated the utility of
extended-release naltrexone (VIVITROL®) in individuals involved in
the criminal justice system. VIVITROL is Alkermes’ (NASDAQ: ALKS)
once-monthly, non-narcotic medication for the prevention of relapse
to opioid dependence, following opioid detoxification. The
open-label, randomized, controlled, effectiveness trial compared
six monthly injections of extended-release naltrexone with usual
treatment (brief counseling and referrals for community treatment
programs, including the option of agonist therapies) for the
prevention of opioid relapse among criminal justice offenders. In
the study, extended-release naltrexone showed a statistically
significant reduction in relapse rates (p<0.001) and, for those
who relapsed, a significantly longer median time to relapse
compared with the usual-treatment group in the six-month treatment
period (p<0.001). Overall, more participants reported adverse
events in the extended-release naltrexone group versus those in the
usual-treatment group, whereas the rate of serious adverse events
was significantly lower in the extended-release naltrexone group,
compared with the usual-treatment group (p=0.006).
Reflective of the growing public health concern of opioid
addiction and its impact on the criminal justice system, the study,
entitled “Extended-Release Naltrexone to Prevent Opioid Relapse in
Criminal Justice Offenders,”1 was sponsored by the National
Institute on Drug Abuse (NIDA) and was led by 17 clinical
researchers and addiction specialists throughout the U.S. The
study’s lead author is Joshua D. Lee, M.D., M.Sc., associate
professor in the departments of Population Health and Medicine at
NYU Langone Medical Center, and the senior author is Charles
O’Brien, M.D., Ph.D., vice chair of Psychiatry at the Perelman
School of Medicine at the University of Pennsylvania and founding
director of Penn’s Center for Studies of Addiction.
Approximately one-third of heroin users pass through
correctional facilities annually in the U.S.2 Nearly 65 percent of
the 2.3 million U.S. prison inmates meet the medical criteria for
substance abuse or addiction, yet only 11 percent receive treatment
during their incarceration.3 In addition, more than half of those
on parole or probation continue to go untreated.4
“The opioid epidemic has put a growing strain on our criminal
justice system where individuals struggling with opioid addiction
are in need of treatment. Since our prisons and criminal justice
system are among the largest providers of addiction services in the
country, it is critical that we expand the range of medication
treatment options available to this population and connect people
to community-based treatment programs,” commented Sheriff James M.
Cummings of Barnstable County, Mass. “In Barnstable, we’ve had
success with VIVITROL as an important component of our program,
which also includes counseling and other support services essential
for individuals to successfully recover and re-enter the community.
VIVITROL may play an important role in the criminal justice system,
as it is a long-acting, non-narcotic, non-addictive opioid
antagonist with no known abuse or diversion potential.”
This NIDA-sponsored study began in 2009, prior to the approval
of extended-release naltrexone for the treatment of opioid
dependence. Consequently, as noted by the authors, extended-release
naltrexone was not widely available to the public sector community
during the treatment period. Today, extended-release naltrexone is
being used in the criminal justice setting in more than 100 pilot
programs throughout 30 states, including drug court, criminal
justice re-entry, legislative and public health initiatives. Each
of these programs is designed with various medication treatment
parameters, psychosocial support and differing scopes of
surrounding community support services.
“It is encouraging to see data showing, in comparison with a
traditional treatment approach, VIVITROL helped to reduce relapse
to opioid dependence and protected against overdoses in this
patient population. It is also reassuring to see that the frequency
of overdoses in patients treated with VIVITROL did not increase
after the medication was discontinued,” stated Adam Bisaga, M.D.,
Professor of Psychiatry at the Columbia University Medical Center
and Research Scientist at the New York State Psychiatric Institute.
“Opioid dependence is a chronic disease that requires an
individualized treatment plan, including psychosocial treatments
and a medication support, along with monitoring that should extend
over the long term to assure the best possible clinical
outcome.”
Results of Study Published in
NEJMThe study compared the use of extended-release
naltrexone versus usual treatment in more than 300 criminal justice
offenders at five sites.5 During the six-month treatment period of
the open-label study, participants were randomized to two arms: one
receiving extended-release naltrexone once monthly and the other
receiving usual treatment (brief counseling and referrals for
community treatment programs, including the option of agonist
therapies) without extended-release naltrexone. The lead
investigators of the study made an independent determination to
select a six-month treatment period for study participants,
followed by discontinuation of extended-release naltrexone in the
treatment group and provision of referrals to local community
treatment programs to all study participants. In addition to
referrals, participants received brief counseling and the option of
agonist therapies. Thirty-seven percent of the usual-treatment
group pursued agonist treatments, primarily after resumed illicit
opioid use and relapse, during the trial.
Data from the study showed that the median time to relapse, the
primary endpoint, was more than two times longer, among those who
relapsed, in participants randomized to extended-release
naltrexone, compared with usual treatment (p<0.001). The
usual-treatment group experienced nearly 50 percent more relapse
events than the extended-release naltrexone group (p<0.001)
during the treatment period. An opioid-relapse event was defined as
10 or more days of opioid use in a 28-day period as assessed by
self-report or by testing urine toxicology samples obtained every
two weeks; a positive or missing sample was computed as five days
of opioid use. Sixty-one percent of patients in the
extended-release naltrexone group participated in all six
injections during the treatment period. While the study was not
powered to show statistical significance for the secondary endpoint
of days of reincarceration, substantially fewer (37%) days of
reincarceration were reported in the extended-release naltrexone
group.
Participants were followed for a total of 78 weeks. Three
follow-up visits occurred during the year following the six-month
treatment period, beginning at Week 27 and at six-month intervals
for both arms. Opioid-use prevention effects waned after
discontinuation of treatment. As noted by the authors in the study,
symptoms of opioid-use disorder are more likely to recur with the
discontinuation of effective pharmacotherapy as with other chronic
diseases.
Overall, more participants reported adverse events in the
extended-release naltrexone group versus those in the
usual-treatment group. The most common adverse events (≥ 10%) related to extended-release naltrexone were
injection-site reaction, headache and gastrointestinal upset.
Significantly fewer serious adverse events occurred with
extended-release naltrexone, compared with the usual-treatment
group. There were no overdose events observed in the
extended-release naltrexone group in the 78-week period compared
with seven overdose events, including three deaths, in the
usual-treatment group.
Alkermes did not have editorial control or access to trial data.
The company contributed VIVITROL in kind through an
investigator-initiated trial contract.
About Opioid DependenceA
chronic brain disease, opioid dependence is characterized by
cognitive, behavioral and physiological symptoms in which an
individual continues to use opioids despite significant harm to
oneself and others.6 The use of heroin, an illegal opioid drug, and
the non-medical use of FDA-approved opioid analgesics, including
prescription pain relievers, represents a growing public health
problem in the U.S. According to the 2014 U.S. National Survey on
Drug Use and Health, an estimated 2.3 million people aged 18 or
older were dependent on pain relievers or heroin in the U.S.7
About
VIVITROL®VIVITROL (naltrexone for
extended-release injectable suspension) is a once-monthly
medication for the treatment of alcohol dependence as well as for
the prevention of relapse to opioid dependence, following opioid
detoxification. VIVITROL is the first and only non-narcotic,
non-addictive, once-monthly medication approved for the treatment
of opioid dependence. Treatment with VIVITROL should be part of a
comprehensive management program that includes psychosocial
support.
IMPORTANT SAFETY INFORMATION
WHAT IS VIVITROL®?
VIVITROL (naltrexone for extended-release injectable suspension)
is a prescription injectable medicine used to:
- Treat alcohol dependence. You should
stop drinking before starting VIVITROL.
- Prevent relapse to opioid dependence
after opioid detox. You must stop taking opioids or other
opioid-containing medications before starting VIVITROL.
VIVITROL must be used with other alcohol or drug recovery
programs such as counseling.
VIVITROL may not work for everyone and has not been studied in
children.
DO NOT TAKE VIVITROL IF YOU:
- Are still using or still have any
symptoms of physical withdrawal due to dependence on opioid street
drugs or opioid-containing medicines.
- Have opioid withdrawal symptoms.
- Are allergic to naltrexone or any of
the ingredients in VIVITROL or the liquid used to mix
VIVITROL.
See the Medication Guide for more information about opioid
withdrawal and the ingredients in VIVITROL and the liquid used to
mix it.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
VIVITROL?
VIVITROL can cause serious side effects, including:
RISK OF OPIOID OVERDOSE
Using opioids, even in amounts that you used before VIVITROL
treatment, can lead to accidental overdose, serious injury, coma or
death. To avoid accidental overdose:
- Do not take large amounts of
opioids or try to overcome the opioid-blocking effects of
VIVITROL.
- Do not use opioids in amounts that you
used before VIVITROL treatment. You may even be more sensitive to
lower amounts of opioids:
- After detox.
- When your next VIVITROL dose is
due.
- If you miss a dose of VIVITROL.
- After you stop VIVITROL treatment.
Get emergency medical help right away if you have trouble
breathing; become very drowsy with slowed breathing; have slow,
shallow breathing; feel faint, dizzy, confused; or have other
unusual symptoms.
SEVERE REACTIONS AT THE INJECTION SITE
VIVITROL may cause severe injection site reactions, including
tissue death. Some injection site reactions have required surgery.
Call your doctor right away if you notice any of the following at
your injection site:
- Intense pain
- The area feels hard
- Swelling
- Lumps
- Blisters
- An open wound
- A dark scab
Tell your doctor about any injection site reaction that concerns
you, gets worse overtime or does not get better by two weeks after
the injection.
SUDDEN OPIOID WITHDRAWAL
To avoid sudden opioid withdrawal, you must stop taking any
opioids or opioid-containing medications, including buprenorphine
or methadone, for at least 7 to 14 days before starting
VIVITROL. If your doctor decides that you don’t need to complete
detox first, he or she may give you VIVITROL in a medical facility
that can treat sudden opioid withdrawal.
Sudden opioid withdrawal can be severe and may require
hospitalization.
LIVER DAMAGE OR HEPATITIS
Naltrexone, the active ingredient in VIVITROL, can cause liver
damage or hepatitis. Tell your doctor if you have any of the
following symptoms of liver problems during VIVITROL treatment:
- Stomach area pain lasting more than a
few days
- Yellowing of the whites of your
eyes
- Dark urine
- Tiredness
OTHER POSSIBLE SIDE EFFECTS
VIVITROL can cause other serious side effects, such
as:
- Depressed mood – Sometimes this
leads to suicide or suicidal thoughts and behavior. Tell those
closest to you that you are taking VIVITROL. You or those closest
to you should call your doctor right away if you become depressed
or have any new or worsening depression symptoms.
- Allergic pneumonia – Tell your
healthcare provider if you have shortness of breath, wheezing or a
cough that doesn’t go away.
- Serious allergic reactions – Get
medical help immediately if you have a skin rash; swelling of your
face, eyes, mouth or tongue; trouble breathing or wheezing; chest
pain; or are feeling dizzy or faint.
Common side effects of VIVITROL include nausea,
tiredness, headache, dizziness, vomiting, decreased appetite,
painful joints, and muscle cramps; in addition, common side effects
in people taking VIVITROL for opioid dependence also include cold
symptoms, trouble sleeping and toothache.
These are not all of the side effects of VIVITROL. For more
information, ask your healthcare provider. Tell your doctor right
away if you have any side effect that does not go away. See the
Medication Guide for more information.
Call your doctor for medical advice about any side effects.
You are encouraged to report negative side effects to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
About Alkermes
Alkermes plc is a fully integrated, global
biopharmaceutical company developing innovative medicines for the
treatment of central nervous system (CNS) diseases. The company has
a diversified commercial product portfolio and a substantial
clinical pipeline of product candidates for chronic diseases that
include schizophrenia, depression, addiction and multiple
sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and
manufacturing facility in Athlone, Ireland; and a manufacturing
facility in Wilmington, Ohio. For more information, please visit
Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking
Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: successful outcomes
using VIVITROL in the criminal justice system; and the growth of
opioid dependence as a disease and public health problem. The
company cautions that forward-looking statements are inherently
uncertain. 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 they are necessarily subject to
a high degree of uncertainty and risk. Actual performance and
results may differ materially from those expressed or implied in
the forward-looking statements due to various risks and
uncertainties. These risks and uncertainties include, among others:
whether VIVITROL will continue to be utilized in the criminal
justice system; whether the outcomes from the use of VIVITROL in
the criminal justice system will be positive; whether opioid
dependence will continue to grow as a public health and criminal
justice problem; and those risks described in the Alkermes plc
Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2015,
and in other subsequent filings made by the company with the U.S.
Securities and Exchange Commission (SEC), which are available on
the SEC’s website at www.sec.gov. The information contained in this
press release is provided by the company as of the date hereof,
and, except as required by law, the company disclaims any intention
or responsibility for updating or revising any forward-looking
information contained in this press release.
VIVITROL® is a registered trademark of Alkermes, Inc.
1 Lee, J. et al. Extended-Release Naltrexone to Prevent Opioid
Relapse in Criminal Justice Offenders. The New England Journal of
Medicine. 2016, 374: 1232-1242.
2 Boutwell, A. et al. Arrested on heroin: a national
opportunity. Journal of Opioid Management. 2007, 3: 328–332.
3 CASAColumbia. Behind Bars II: Substance Abuse and America’s
Prison Population. Accessed on March 30, 2016 from
http://www.centeronaddiction.org/download/file/fid/487.
4 Legal Action Center. Confronting an Epidemic: The Case for
Eliminating Barriers to Medication Assisted Treatment of Heroin and
Opioid Addiction. Accessed on March 30, 2016 from
http://lac.org/wp-content/uploads/2014/07/LAC-The-Case-for-Eliminating-Barriers-to-Medication-Assisted-Treatment.pdf.
5 University of Pennsylvania (Philadelphia), New York University
School of Medicine and Bellevue Hospital Center (New York), Rhode
Island Hospital and Brown University (Providence, Rhode Island),
Columbia University Medical Center (New York), and Friends Research
Institute (Baltimore).
6 DSM-IV-TR, American Psychiatric Association.
7 SAMHSA. Behavioral Health Trends in the United States: Results
from the 2014 National Survey on Drug Use and Health. Accessed on
March 30, 2016 from
http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf.
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Alkermes Contacts:For
Investors:Sandra Coombs, +1 781-609-6377orFor Media:Jennifer
Snyder, +1 781-609-6166
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