FDA Approves Sublocade as a Monthly Injection for Opioid Addiction

The Food and Drug Administration approved a new weapon in the fight against opioid use disorder (OUD) at the end of November. Sublocade is a once-a-month injectable form of buprenorphine, a medication used in treating people with moderate to severe opioid addiction.

Sublocade Monthly Injection for Opioid Use Disorder

“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety,” FDA Director Dr. Scott Gottlieb said in a statement.

Buprenorphine is one of the most effective ways of treating opioid dependence. It curbs the desire and cravings to use heroin or prescription painkillers.

Like methadone, it’s considered a replacement therapy, though patients can start taking the medication even before detox.

Until now, buprenorphine, which goes by the brand name Suboxone, was only available as a daily tablet or a small film that dissolved under the tongue.

A once monthly injection, like Sublocade, removes the burden and decision to take the medication on a day-to-day basis. For many people, this will likely be a game-changer and put Sublocade in line with Vivitrol, a similar monthly injection that’s shown promise.

Sublocade Clinical Trial Studies

The manufacturer of Sublocade, Indivior, a London based pharmaceutical company, ran two clinical studies before approval that involved some of the following:

Included more than 800 adults with moderate to severe opioid use disorder
In each clinical trial, one group received Sublocade injections every month while the other received a placebo
The control group that received the medication reported fewer opioid relapses in a six-month period and passed more urine tests than the group that received just the placebo

“This could be the first-line [medication] for opioid addiction,” Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University, said in an interview. “It could open up opportunities for getting more patients buprenorphine.”

Why are More Treatment Options Needed?

The National Institute on Drug Abuse (NIDA) reported in September that a staggering 64,000 Americans died from drug overdoses in 2016. According to the agency’s data, the spike in overdose deaths is largely a result of heroin laced with fentanyl, a synthetic opioid so potent that a miniscule amount can be deadly if absorbed through bare skin.

The opioid epidemic has healthcare professionals, addiction specialists, law enforcement, and legislators scrambling to find a solution.

Drug overdose has become the leading cause of death among Americans under the age 50, which is why innovation and new treatment options are so critically important.

To its credit, the FDA saw so much promise in the new medication assisted treatment (MAT) that it placed Sublocade on priority review – the goal of reviewing an approval application in six months.

They also fast-tracked it, which is the agency’s process of expediting approval so that important new medications get into the hands of physicians quicker.

Hopefully Sublocade will provide another important resource in the fight against the opiate epidemic and find relief for so many people with opioid use disorder.

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