FDA OKs Once-Monthly Injectable Treatment for Opioid Use Disorder

FDA officials have approved the first once-monthly buprenorphine injectable product, Sublocade (Indivior), for the treatment of moderate-to-severe opioid use disorder (OUD).

The drug is indicated for adult patients with OUD who have initiated treatment with a transmucosal buprenorphine-containing product, and have been on a stable dose of buprenorphine treatment for at least 7 days. Buprenorphine was previously approved for the treatment of OUD as a tablet, film, or implant.

Sublocade is a drug-device combination product that utilizes buprenorphine and the Atrigel Delivery System in a pre-filled syringe. It is intended to be administered only by health care providers and used as part of a complete treatment program that includes counseling and psychosocial support.

The approval is based on 2 clinical studies evaluating use of the product in 848 adults diagnosed with moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film. Once on a stable dose, the participants were given Sublocade by injection, with the response measured by urine drug screening and self-reporting of illicit opioid use over the 6-month treatment period. Patients treated with Sublocade were found to have had more weeks without positive urine tests or self-reports of opioid use than those in the control group. A higher portion of patients also had no evidence of illicit opioid use throughout the treatment period compared to the placebo group.

The most common adverse effects associated with the use of Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching at the injection site, and abnormal liver function tests.

The treatment contains a boxed warning against intravenous self-administration. According to the statement, if the product were to be administered intravenously rather than subcutaneously, the solid mass could cause blockage, tissue damage, or embolus.

Additionally, Sublocade must be prescribed or dispensed as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients. The product will be issued to health care providers through a restricted program, administered only by providers in a health care setting, and will require health care settings and pharmacies that dispense Sublocade to complete an enrollment form stating that they have procedures in place to ensure that the product is dispensed only to providers and not directly to patients.

Reference

1. FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder [news release]. FDA’s website.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm?utm_campaign=11302017_PR_FDA%20approves%20bunep&utm_medium=email&utm_source=Eloqua. Accessed December 1, 2017.