DUBLIN--(BUSINESS WIRE)-- 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:
VIVITROL is contraindicated in patients:
WARNINGS AND PRECAUTIONS
Vulnerability to Opioid Overdose:
Injection Site Reactions:
Precipitation of Opioid Withdrawal:
- 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.
Depression and Suicidality:
When Reversal of VIVITROL Blockade Is Required for Pain Management:
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.
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 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.
Eva Stroynowski, +1 781-609-6823
Sandy Coombs, +1 781-609-6377
Matthew Henson, +1 781-609-6637
Source: Alkermes plc