The monthly injection has the potential to reduce dangerous relapses that occur when patients stop taking their daily medication. But that benefit has not yet been established.
The Food and Drug Administration approved the injectable drug from Indivior (In-div-EE-or) for adults with opioid use disorder who are already on stable doses of the addiction medication.
The approval Thursday comes amid the deadliest drug epidemic in U.S. history. More than 64,000 Americans died from drug overdoses last year, mostly from opioids.
Indivior already sells the drug in medicated strips that dissolve under the tongue. Patients take the medication daily to control opioid withdrawal symptoms.
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