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Published: Jun 30, 2021
DUBLIN, June 30, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced the presentation of new health economics and outcomes research related to healthcare resource use (HRU) among veterans with alcohol dependence at the 2021 Research Society on Alcoholism (RSA) Scientific Meeting/International Society for Biomedical Research on Alcoholism (ISBRA) Conference, which took place virtually June 19-23, 2021.
The company presented results from a retrospective, observational study using data from the Veterans Health Administration (VHA) database, which includes healthcare encounters, treatments and laboratory tests at VHA facilities. The study assessed treatment patterns and HRU among 3,665 patients diagnosed with alcohol dependence who were treated with VIVITROL® (naltrexone for extended-release injectable suspension (XR-NTX)).
In the study, VIVITROL treatment for alcohol dependence was associated with decreases in inpatient care and increases in outpatient care during the one-year period following initiation of treatment with VIVITROL, compared to the one-year period before VIVITROL treatment initiation. Specifically:
These HRU changes may reflect a possible transition to less resource-intensive care for veterans initiating VIVITROL. The generalizability of these results to the U.S. population may be limited.
“Alkermes is committed to advancing research on substance use disorders and veterans represent an important demographic given the pervasiveness of alcohol dependence and the broad unmet medical need within the veteran community,” said Amy O’Sullivan, Vice President, Health Economics & Outcomes Research. “Though more research is needed, the VHA dataset provides insight into how the use of VIVITROL may impact engagement in treatment, healthcare resource utilization, and health outcomes in this patient population.”
Details of the poster presentation at RSA are as follows:
Alkermes previously presented data from another retrospective, observational study using the same VHA database at the Association of Military Surgeons of the United States (AMSUS), The Society of Federal Health Professionals, Annual Meeting in December 2020. That study was one of the first studies to provide insights into the patient journey among veterans from alcohol dependence diagnosis to VIVITROL initiation and beyond. Patients studied had extensive health care use and carried a high burden of chronic disease, including hypertension (40.5 percent), chronic pain (10.8 percent), and diabetes (9.7 percent). In addition, a majority had diagnoses for mental health comorbidities, such as depression (74.1 percent), non-alcohol/opioid substance use disorder (66.3 percent), and post-traumatic stress syndrome (52.9 percent). Key findings included:
About Alcohol Dependence
Alcohol dependence is a chronic, relapsing disease that poses serious and potentially fatal health risks.1 In 2017, it affected nearly 8 million people aged 12 and older in the U.S., with a significant burden on veterans.2
VIVITROL® (naltrexone for extended-release injectable suspension) is a once-monthly medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. For more information, visit www.vivitrol.com.
VIVITROL is indicated for:
VIVITROL is contraindicated in patients:
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Vulnerability to Opioid Overdose:
Injection Site Reactions:
Precipitation of Opioid Withdrawal:
Depression and Suicidality:
When Reversal of VIVITROL Blockade Is Required for Pain Management:
Hypersensitivity Reactions including Anaphylaxis:
Interference with Laboratory Tests
You are encouraged to report side effects to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Alkermes plc
Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. 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 value of VIVITROL and the potential impacts of the treatment of alcohol dependence with VIVITROL on healthcare resource utilization and health outcomes. You are cautioned 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 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 the results of these retrospective, observational studies will be predictive of future results 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, 2020 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 Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Substance Use Disorders (SUD). 2015. Available from: https://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGrevised22216.pdf.
2 GBD 2016 Alcohol and Drug Use Collaborators. The global burden of disease attributable to alcohol and drug use in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Psychiatry. 2018 Dec;5(12):987-1012. doi: 10.1016/S2215-0366(18)30337-7.
For Investors: Sandy Coombs, +1 781 609 6377
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SOURCE Alkermes plc
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