Injectable opiate substitution treatment approved by FDA

03 June 2016
Person passed out on the couch after injecting heroin

An injectable version of the opiate substitution treatment (OST) buprenorphine – which is delivered through an implant – has been approved for use in the USA by the Food and Drug Administration (FDA). The drug, Probuphine, is a long-acting injectable that will help patients to manage the withdrawal effects of stopping heroin and other opiates, and offers another option for managing addiction in people who use drugs.

The USA is currently grappling a rising opiate addiction problem – particularly heroin – which has resulted in several outbreaks of HIV across the US Midwest. People most affected have been young, white people living in poor rural and suburban areas.

The buprenorphine implant will release a constant low-level dose of the opiate substitute over six months, and can be made available to patients already on a treatment programme involving a moderate to low-level dosage of buprenorphine.

The implant will eliminate the need for people to make clinic visits every day, and could be particularly advantageous for people living in rural locations, or where there is no clinic close to them. It also means that the pill cannot be lost, forgotten or stolen.

FDA Commissioner Robert M. Califf, M.D. said: "Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives.“ It is the first-ever implant option for opiate-abuse recovery.

The provision of opiate substitution treatment, methadone or buprenorphine, in lieu of heroin, has been shown to reduce injecting drug use behaviours and limit the risk of HIV transmission. It has also been shown to improve access and adherence to treatment, reduce instances of overdosing and associated deaths, and also improve the physical and mental health of people who inject drugs.

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