Results from a National Institute on Drug Abuse (NIDA)-funded
study, were published in The Lancet today, comparing
extended-release naltrexone (VIVITROL®) and buprenorphine-naloxone,
two options for opioid dependence. This is the second study
published in the past month comparing these two medications and it
provides additional evidence supporting the use of VIVITROL as an
effective treatment option for patients. Against the backdrop of a
national opioid crisis, Medication-Assisted Treatment (MAT) is
substantially underutilized. Data from the study reinforce the
value of MAT and the distinct differences between two important
options for this devastating disease.
VIVITROL represents a different approach to treating opioid
dependence. VIVITROL is an injectable, once-monthly,
extended-release form of naltrexone, an opioid receptor antagonist.
Buprenorphine-naloxone is an opioid partial agonist. In a
previously published journal article discussing the NIDA study
design, the study investigators observed, “Agonists and antagonists
are diametrically opposite in domains ranging from pharmacology to
treatment philosophy. Agonists maintain physical tolerance and
opioid dependence; antagonists block any opioid effects and are not
psychoactive or habit-forming.1”
VIVITROL was developed by Alkermes (NASDAQ: ALKS). It was
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of alcohol dependence in 2006 and for the prevention of
relapse to opioid dependence, following opioid detoxification, in
2010. Since its first approval, more than 350,000 patients have
been treated with VIVITROL.
“VIVITROL is an entirely different approach from maintenance
therapies. VIVITROL works by blocking opioid receptors in the brain
and is the only FDA-approved medication for preventing relapse to
opioid dependence, following opioid detoxification,” said Craig
Hopkinson, M.D., Chief Medical Officer and Senior Vice President of
Clinical Development and Medical Affairs at Alkermes. “This study
highlights the importance of detoxification for initiating
treatment with VIVITROL. Alkermes is working alongside prominent
researchers in the field to determine effective, safe and efficient
detoxification strategies for successful induction onto VIVITROL,
in order to help healthcare providers manage their patients through
this critical transition period.”
“These data confirm and build on the body of evidence supporting
the value of Medication-Assisted Treatment, and VIVITROL is an
important element of the nation’s response to treating opioid
dependence. Addiction is a highly complex disease, and no single
treatment option is right for all patients,” said Richard Pops,
Chief Executive Officer of Alkermes. “In order to address this
epidemic, the treatment system for opioid addiction must evolve to
embrace data-driven, patient-centered care customized to the
clinical needs of each individual. We remain committed to working
alongside healthcare providers, policymakers and public health
officials to ensure access to all FDA-approved medications for this
underserved population. Patients need greater access to medicines
that work.”
We are in the midst of a public health crisis, and only a small
percentage of patients suffering from opioid use disorder are
getting treatment. Alkermes applauds NIDA’s commitment to advancing
research focused on treatment options, as it is effective and
significantly underutilized despite the large and growing body of
evidence supporting the use of medication to treat the disease.
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.2 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 2016 U.S. National Survey on
Drug Use and Health, nearly 2 million people aged 18 or older had
an opioid use disorder.3
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 a 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
INDICATIONS
VIVITROL® is indicated for:
- Treatment of alcohol dependence in
patients who are able to abstain from alcohol in an outpatient
setting prior to initiation of treatment with VIVITROL. Patients
should not be actively drinking at the time of initial VIVITROL
administration.
- Prevention of relapse to opioid
dependence, following opioid detoxification.
- VIVITROL should be part of a
comprehensive management program that includes psychosocial
support.
CONTRAINDICATIONS
VIVITROL is contraindicated in patients:
- Receiving opioid analgesics
- With current physiologic opioid
dependence
- In acute opioid withdrawal
- Who have failed the naloxone challenge
test or have a positive urine screen for opioids
- Who have exhibited hypersensitivity to
naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose,
or any other components of the diluent
WARNINGS AND PRECAUTIONS
Vulnerability to Opioid Overdose:
- After opioid detoxification, patients
are likely to have a reduced tolerance to opioids. VIVITROL blocks
the effects of exogenous opioids for approximately 28 days after
administration. As the blockade wanes and eventually dissipates
completely, use of previously tolerated doses of opioids could
result in potentially life-threatening opioid intoxication
(respiratory compromise or arrest, circulatory collapse,
etc.).
- Cases of opioid overdose with fatal
outcomes have been reported in patients who used opioids at the end
of a dosing interval, after missing a scheduled dose, or after
discontinuing treatment. Patients and caregivers should be told of
this increased sensitivity to opioids and the risk of
overdose.
- Although VIVITROL is a potent
antagonist with a prolonged pharmacological effect, the blockade
produced by VIVITROL is surmountable. The plasma concentration of
exogenous opioids attained immediately following their acute
administration may be sufficient to overcome the competitive
receptor blockade. This poses a potential risk to individuals who
attempt, on their own, to overcome the blockade by administering
large amounts of exogenous opioids.
- Any attempt by a patient to overcome
the VIVITROL blockade by taking opioids may lead to fatal overdose.
Patients should be told of the serious
consequences of trying to overcome the opioid blockade.
Injection Site Reactions:
- VIVITROL injections may be followed by
pain, tenderness, induration, swelling, erythema, bruising, or
pruritus; however, in some cases injection site reactions may be
very severe.
- Injection site reactions not improving
may require prompt medical attention, including, in some cases,
surgical intervention.
- Inadvertent subcutaneous/adipose layer
injection of VIVITROL may increase the likelihood of severe
injection site reactions.
- Select proper needle size for patient
body habitus, and use only the needles provided in the carton.
- Patients should be informed that any
concerning injection site reactions should be brought to the
attention of their healthcare provider.
Precipitation of Opioid Withdrawal:
- When withdrawal is precipitated abruptly by administration
of an opioid antagonist to an
opioid-dependent patient, the resulting withdrawal syndrome
can be severe. Some cases of withdrawal symptoms have been severe
enough to require hospitalization, and in some cases, management in
the ICU.
- To prevent occurrence of precipitated
withdrawal, opioid-dependent patients, including those being
treated for alcohol dependence, should be opioid-free (including
tramadol) before starting VIVITROL treatment:
- An opioid-free interval of a minimum of 7–10 days is
recommended for patients previously dependent on short-acting
opioids.
- Patients transitioning from buprenorphine or methadone may be
vulnerable to precipitated withdrawal for as long as two weeks.
- If a more rapid transition from agonist
to antagonist therapy is deemed necessary and appropriate by the
healthcare provider, monitor the patient closely in an appropriate
medical setting where precipitated withdrawal can be managed.
- Patients should be made aware of the
risk associated with precipitated withdrawal and be encouraged to
give an accurate account of last opioid use.
Hepatotoxicity:
- Cases of hepatitis and clinically
significant liver dysfunction have been observed in association
with VIVITROL. Warn patients of the risk of hepatic injury; advise
them to seek help if experiencing symptoms of acute hepatitis.
Discontinue use of VIVITROL in patients who exhibit acute hepatitis
symptoms.
Depression and Suicidality:
- Alcohol- and opioid-dependent patients
taking VIVITROL should be monitored for depression or suicidal
thoughts. Alert families and caregivers to monitor and report the
emergence of symptoms of depression or suicidality.
When Reversal of VIVITROL Blockade Is Required for Pain
Management:
- For VIVITROL patients in emergency
situations, suggestions for pain management include regional
analgesia or use of non-opioid analgesics. If opioid therapy is
required to reverse the VIVITROL blockade, patients should be
closely monitored by trained personnel in a setting staffed and
equipped for CPR.
Eosinophilic Pneumonia:
- Cases of eosinophilic pneumonia
requiring hospitalization have been reported. Warn patients of the
risk of eosinophilic pneumonia and to seek medical attention if
they develop symptoms of pneumonia.
Hypersensitivity Reactions:
- Patients should be warned of the risk
of hypersensitivity reactions, including anaphylaxis.
Intramuscular Injections:
- As with any IM injection, VIVITROL
should be administered with caution to patients with
thrombocytopenia or any coagulation disorder.
Alcohol Withdrawal:
- Use of VIVITROL does not eliminate nor
diminish alcohol withdrawal symptoms.
ADVERSE REACTIONS
- Serious adverse reactions that may be
associated with VIVITROL therapy in clinical use include severe
injection site reactions, eosinophilic pneumonia, serious allergic
reactions, unintended precipitation of opioid withdrawal,
accidental opioid overdose, and depression and suicidality.
- The adverse events seen most frequently
in association with VIVITROL therapy for alcohol dependence (ie,
those occurring in ≥5% and at least twice as frequently with
VIVITROL than placebo) include nausea, vomiting, injection site
reactions (including induration, pruritus, nodules, and swelling),
muscle cramps, dizziness or syncope, somnolence or sedation,
anorexia, decreased appetite or other appetite disorders.
- The adverse events seen most frequently
in association with VIVITROL in opioid-dependent patients (ie,
those occurring in ≥2% and at least twice as frequently with
VIVITROL than placebo) were hepatic enzyme abnormalities, injection
site pain, nasopharyngitis, insomnia, and toothache.
You are encouraged to report side effects to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see Full Prescribing Information for
VIVITROL.
About AlkermesAlkermes
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 StatementsCertain
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 the potential therapeutic
and commercial value of VIVITROL and improvements to the treatment
system for opioid dependence. 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 clinical results for
VIVITROL will be predictive of commercial results and success; and
those risks and uncertainties described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K for the year
ended Dec. 31, 2016 and Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2017 and Sept. 30, 2017 and in 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. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release.
VIVITROL® is a registered trademark of Alkermes, Inc.
1 Lee, J.D., et al. (2016). “NIDA Clinical Trials Network
CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid
Treatment (X:BOT): Study design and rationale.” Contemporary
Clinical Trials 50, 253-264.
2 DSM-IV-TR, American Psychiatric Association.
3 SAMHSA. Behavioral Health Trends in the United States:
Results from the 2016 National Survey on Drug Use and Health.
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