FDA Approves New Drug to Treat Opioid Addiction

Yesterday the US Food and Drug Administration approved the first monthly, injectable form of buprenorphine, a widely used treatment for opioid addiction. It's an injection that improves on current versions of the drug, which have to be taken daily as a pill or dissolvable film. Experts believe this new, extended-release form can actually be more convenient for some people, and adherence to addiction medication could help prevent relapses and overdoses. Injectable buprenorphine can change the market for opioid-addiction treatments; it may also help curb concerns among law enforcement about the drug’s potential for abuse or diversion.

“It’s potentially a game changer,” Andrew Kolodny, co-director of opioid policy research at Brandeis University, told STAT. “This could become first-line [medication] for opioid addiction. It could open up opportunities for getting more patients on buprenorphine.”

Buprenorphine is one option for what’s known as medication-assisted treatments (MAT), which are part of the FDA’s plan to combat the opioid crisis: An estimated 50,000 people died of opioid overdoses in 2016. MAT combines medications (methadone, buprenorphine, or naltrexone) with counseling and behavioral therapy to treat opioid abuse, which is clinically referred to as opioid use disorder (OUD).

Buprenorphine is itself an opioid which reduces withdrawal symptoms and the craving for opioids, while removing patients from the roller coaster of euphoric highs and crushing lows that come with opioid misuse or abuse. It also blunts the effects of other opioids, making them less attractive for patients who want to quit using. The Substance Abuse and Mental Health Services Administration says patients undergoing MAT cut their risk of death in half.

But up to this point, patients using buprenorphine had to take it daily, either as a pill or as a film that dissolved under the tongue. That made some authorities concerned that buprenorphine simply “substitutes” one opioid for another and that the pills could be diverted or abused—a powerful misconception that interferes with people getting these effective treatments, especially within the criminal justice system.

With this new form, made by Indivior under the brand name Sublocade, those in treatment will still have to begin by taking buprenorphine under the tongue for seven days. After that stabilization period, they can receive monthly injections in the abdomen. Sublocade is expected to be available in the first quarter of 2018. (A second company is seeking FDA approval for a different monthly injection that wouldn’t require people to take the tablets first; they expect a decision by January 19.)

The new drug could be an improvement on the previous extended-release injection, naltrexone, sold under the brand name Vivitrol, because it doesn’t require patients to undergo a painful three-day period of withdrawal before they can get the shot. In a recent study, four times more patients failed to start the long-acting naltrexone, compared to those randomly assigned to take buprenorphine.

In a press release touting the decision, the FDA described the approval as part of an effort to get more treatment options into the hands of people who can use them. “We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction,” Commissioner Scott Gottlieb added.

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