VIVITROL® and Value of Medication-Assisted Treatment for Opioid Dependence Featured in Study Sponsored by National Institute on Drug Abuse
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 Dependence
A 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
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
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.
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.
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