A new form of a widely used opioid addiction treatment that is injected monthly instead of taken daily as a tablet was approved Thursday by the Food and Drug Administration. Experts say the eagerly anticipated new version of the drug may help patients reduce relapses, disrupt the treatment market, and possibly dispel misconceptions about the drug’s potential for abuse.
Indivior is the first company to gain approval for a monthly injection of buprenorphine. The company is best known for Suboxone, a daily formulation that combines buprenorphine with naloxone into a film that dissolves under the tongue.
“It’s potentially a game changer,” said Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University. “This could become first-line [medication] for opioid addiction. It could open up opportunities for getting more patients on buprenorphine.”
The new product, known as Sublocade, was one of two long-acting buprenorphine injectable products before the FDA. Approval for Indivior’s drug was anticipated after an advisory panel voted 18 to 1 to recommend it in October. A decision on a similar medication made by Braeburn Pharmaceuticals is expected early next year.