The Food and Drug Administration (FDA) has approved Indivior’s long-acting injectable Sublocade (buprenorphine), a monthly injection to treat moderate to severe opioid use disorder among adults who have already been treated with a buprenorphine-containing product that is absorbed through mucous membranes. This is the first long-acting opioid addiction treatment of its kind.

Buprenorphine treatment reduces the withdrawal symptoms associated with opioid use, the cravings for such drugs and, at a proper dose, the pleasure associated with opioid use.

Sublocade, which is injected subcutaneously by a health care worker once per month, should be prescribed as a part of an addiction-treatment program including counseling and psychological support. In clinical trials, a monthly injection of Sublocade yielded sustained therapeutic blood levels of the medication.

The safety and efficacy of Sublocade were established in two clinical studies, one that was a randomized controlled trial and another that was open-label, meaning participants knew whether they were receiving the drug. Together, the studies included 848 adults diagnosed with moderate to severe opioid use disorder who had started treatment with a film of buprenorphine and naloxone absorbed under the tongue and who were switched to Sublocade.

Compared with those who did not receive the treatment, those who received Sublocade had more weeks without positive urine tests for opioids or self-reports of using them. Additionally, a higher proportion of those on Sublocade had no evidence of illicit opioid use throughout the study period, compared with those who received a placebo.

The most common side effects among those receiving Sublocade included constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching at the injection site and abnormal liver function tests.

The safety and efficacy of Sublocade have not been established in minors. Additionally, studies of the treatment did not include those older than 65.

To read an FDA press release on the approval, click here.