FDA approves Indivior’s monthly injection to treat opioid addiction

Summary and Analysis…

This article covers the first long-acting form of Suboxone approved by the FDA. It is hoped that by moving to a long-acting form of Suboxone administered in doctors’ offices that some of the current problems with Suboxone diversion will be reduced. The FDA is expected to rule on a second long-acting form of Suboxone from Braeburn Pharmaceuticals this month. (Braeburn was involved in some controversy last year when it was discovered it had secretly funded a pro-Medication-Assisted Treatment publicity campaign mounted by the recently established Advocates for Opioid Recovery.)

Dr. Andrew Kolodny, an expert quoted in the article suggests the new long-acting forms “could open up opportunities for getting more patients on buprenorphine.”

Recent history indicates that every attempt to increase distribution of opioids while reducing diversion has resulted in more diversion — unethical prescribers, heavy drug company marketing and the unfortunate ingenuity of the community of addicts have consistently found ways to divert and abuse new forms of opioids.

So, although the long-acting form holds promise, potential unintended consequences and dangers should be carefully evaluated by community leaders and policy makers when planning for its use.

Excerpted from STAT

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.