Alkermes med Vivitrol study published in New England Journal of Medicine

Alkermes med made in Wilmington

By Gary Huffenberger -

DUBLIN, Ireland — Results from a study published this week in the prestigious New England Journal of Medicine demonstrate the utility of extended-release naltrexone (Vivitrol®) in opioid-dependent individuals in the criminal justice system, stated an Alkermes media release Thursday.

Vivitrol is Alkermes’ once-monthly medication for the prevention of relapse to opioid dependence, following opioid detoxification. It is manufactured at Alkermes’s facility in Wilmington.

According to the release, current Vivitrol use in the criminal justice setting highlights the importance of medication along with continuity of care, including community-based addiction recovery support.

Reflective of a growing public health concern about opioid addiction and its impact on the criminal justice system, the study, entitled “Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders,” was sponsored by the National Institute on Drug Abuse (NIDA).

The study began in 2009, prior to the approval of extended-release naltrexone for the treatment of opioid dependence. Consequently, as noted by the study’s authors, extended-release naltrexone was not widely available to the public sector community during the treatment period.

Today, extended-release naltrexone is being used in the criminal justice setting in more than 100 pilot programs in 30 states, including drug court, criminal justice re-entry, legislative and public health initiatives. Each of these programs is designed with various medication treatment, psychosocial support and differing scopes of surrounding community support services, the release stated.

“It is encouraging to see data showing, in comparison with a traditional treatment approach, Vivitrol helped to reduce relapse to opioid dependence and protected against overdoses in this patient population. It is also reassuring to see that the frequency of overdoses in patients treated with Vivitrol did not increase after the medication was discontinued,” said Adam Bisaga, M.D., professor of psychiatry at the Columbia University Medical Center and a research scientist at the New York State Psychiatric Institute.

“Opioid dependence is a chronic disease,” Bisaga said, “that requires an individualized treatment plan, including psychosocial treatments and a medication support, along with monitoring that should extend over the long term to assure the best possible clinical outcome.”

The study compared the use of extended-release naltrexone versus usual treatment in more than 300 criminal justice offenders at five sites. Participants were followed for a total of 78 weeks.

The study was led by 17 clinical researchers and addiction specialists. The study’s lead author is Joshua D. Lee, M.D., M.Sc., associate professor in the departments of Population Health and Medicine at NYU Langone Medical Center.

The release stated opioid dependence is a chronic brain disease, characterized by cognitive, behavioral and physiological symptoms in which an individual continues to use opioids despite significant harm to oneself and others.

According to the 2014 U.S. National Survey on Drug Use and Health, an estimated 2.3 million people age 18 or older were dependent on pain relievers or heroin in the United States.

Reach Gary Huffenberger at 937-556-5768 or on Twitter @GHuffenberger.
Alkermes med made in Wilmington

By Gary Huffenberger