Alkermes plc announced the presentation of new health economics and outcomes research related to health care resource use (HRU) among veterans with alcohol addiction 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 to 23, 2021.
The company presented results from a retrospective, observational study using data from the Veterans Health Administration (VHA) database, which includes health care encounters, treatments, and laboratory tests at VHA facilities. The study assessed treatment patterns and HRU among 3,665 consumers diagnosed with alcohol addiction who were treated with VIVITROL® (naltrexone for extended-release injectable suspension (XR-NTX)).
In the study, VIVITROL treatment for alcohol addiction 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:
During the baseline period, defined as the one year before VIVITROL initiation, 61.5% of consumers had at least one inpatient admission, and 39.8% of consumers had an emergency department visit.
During the follow up period, defined as one year after VIVITROL initiation, 37.8% of consumers had at least one inpatient admission and 35.4% of consumers had an emergency department visit.
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.
Details of the poster presentation at RSA are as follows:
- Poster #240: “Treatment Patterns and Healthcare Resource Use Among Patients with Alcohol Dependence who Initiated Extended-Release Naltrexone: An Analysis of Veterans Affairs Data,” was presented Sunday, June 20.
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 consumer journey among veterans from alcohol addiction diagnosis to VIVITROL initiation and beyond. Consumers studied had extensive health care use and carried a high burden of chronic disease, including hypertension (40.5%), chronic pain (10.8%), and diabetes (9.7%). In addition, a majority had diagnoses for mental health comorbidities, such as depression (74.1%), non-alcohol/opioid addiction (66.3%), and post-traumatic stress syndrome (52.9%). Key findings included:
- Although 25% of consumers initiated VIVITROL within 60 days of diagnosis, the average time from initial diagnosis to VIVITROL initiation was analogous to 13.6 months.
- While many of the consumers studied (75.8%) received oral naltrexone prior to initiating VIVITROL, 22.0% initiated VIVITROL as first-line medication. Additionally, about half of the consumers studied (46.6%) did not initiate other alcohol addiction medications during the study period following initiation of treatment with VIVITROL.
Alcohol addiction is a chronic, relapsing disease that poses serious and potentially fatal health risks. In 2017, it affected nearly 8 million people aged 12 and older in the U.S., with a significant burden on veterans.
VIVITROL® (naltrexone for extended-release injectable suspension) is a once-monthly medication for the treatment of alcohol addiction and for the prevention of relapse to opioid addiction, following opioid medication 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:
- Treatment of alcohol addiction in consumers who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Consumers should not be actively drinking at the time of initial VIVITROL administration.
- Prevention of relapse to opioid addition, following opioid medication detoxification.
- VIVITROL should be part of a comprehensive management program that includes psychosocial support.
VIVITROL is contraindicated in consumers:
- Receiving opioid medication analgesics
- With current physiologic opioid addiction
- In acute opioid medication withdrawal
- Who have failed the naloxone challenge test or have a positive urine screen for opioid medications
- Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Vulnerability to Opioid Medication Overdose:
- After opioid medication detoxification, consumers are likely to have a reduced tolerance to opioid medications. VIVITROL blocks the effects of exogenous opioid medications for approximately 28 days after administration. As the blockade wanes and eventually dissipates completely, use of previously tolerated doses of opioid medications could result in potentially life-threatening opioid medication intoxication (respiratory compromise or arrest, circulatory collapse, etc.).
- Cases of opioid medication overdose with fatal outcomes have been reported in consumers who used opioid medications at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Consumers and caregivers should be told of this increased sensitivity to opioid medications and the risk of overdose. Discuss the availability of naloxone for the emergency treatment of opioid medication overdose with the consumer and caregiver, at the initial VIVITROL injection and with each subsequent injection. Strongly consider prescribing naloxone for the emergency treatment of opioid medication overdose.
- Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioid medications 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 opioid medications.
- Any attempt by a consumer to overcome the VIVITROL blockade by taking opioid medications may lead to fatal overdose. Consumers should be told of the serious consequences of trying to overcome the opioid medication blockade.
Injection Site Reactions:
- VIVITROL must be prepared and administered by a health care provider.
- 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.
- In the clinical trials, one consumer developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision.
- 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 consumer body habitus and use only the needles provided in the carton.
- Consumers should be informed that any concerning injection site reactions should be brought to the attention of their health care provider.
Precipitation of Opioid Medication Withdrawal:
- When withdrawal is precipitated abruptly by administration of an opioid medication antagonist to an opioid medication-addicted consumer, 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 addicted consumers, including those being treated for alcohol addiction, should be opioid medication-free (including tramadol) before starting VIVITROL treatment:
- An opioid medication-free interval of a minimum of 7–10 days is recommended for consumers previously addicted to short-acting opioid medications.
- Consumers 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 health care provider, monitor the consumer closely in an appropriate medical setting where precipitated withdrawal can be managed.
- Consumers should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid medication use.
- Precipitated opioid medication withdrawal has been observed in alcohol-addicted consumers in circumstances where the prescriber had been unaware of the additional use of opioid medications or co-dependence on opioid medications.
- Cases of hepatitis and clinically significant liver dysfunction have been observed in association with VIVITROL. Warn consumers of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in consumers who exhibit acute hepatitis symptoms.
Depression and Suicidality:
- Alcohol- and opioid medication-addicted consumers 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 consumers in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid medication analgesics. If opioid medication therapy is required to reverse the VIVITROL blockade, consumers should be closely monitored by trained personnel in a setting staffed and equipped for CPR.
- Consumers who develop dyspnea and hypoxemia should seek medical attention immediately. Consider the possibility of eosinophilic pneumonia in consumers who do not respond to antibiotics.
Hypersensitivity Reactions including Anaphylaxis:
- Cases of urticaria, angioedema, and anaphylaxis have been observed with the use of VIVITROL.
- Consumers should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
- In the event of a hypersensitivity reaction, consumers should be advised to seek immediate medical attention in a health care setting prepared to treat anaphylaxis. The consumer should not receive any further treatment with VIVITROL.
- As with any intramuscular injection, VIVITROL should be administered with caution to consumers with thrombocytopenia or any coagulation disorder.
- Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.
Interference with Laboratory Tests
- VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioid medications) in urine.
- For further information, reference to the specific immunoassay instructions is recommended.
- The adverse events seen most frequently in association with VIVITROL therapy for alcohol addiction (i.e., 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), arthralgia, arthritis, or joint stiffness, 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 medication-addicted consumers (i.e., 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 U.S. Food & Drug Administration (FDA).
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.
This was reported by Alkermes on June 30, 2021.
Contact information: Marisa Borgasano, Associate Director, Corporate Communications, Public Affairs, Alkermes plc, Waltham, Massachusetts Facility, 852 Winter Street, Waltham, MA 02451; 781-609-6659; Website: http://www.alkermes.com; or https://www.myrelationshipwithalcohol.com/