Monthly buprenorphine injection could be another favorable option for treating opioid use disorder

Extended-release buprenorphine ([BUP-XR] Sublocade—Indivior) was more successful than placebo in treating patients with opioid use disorder, according to study results published in the Lancet.

BUP-XR was approved by FDA in 2017 as a monthly long-acting injection used to treat patients who have moderate to severe opioid use disorder.

The randomized, double-blind, placebo-controlled trial took place at 36 U.S. treatment centers from January 2015 to November 2015. Eligible participants—504 in total between the ages of 18 and 65—received either six injections of BUP-XR 300 mg or two injections of 300 mg with four injections of 100 mg. The final group was given a volume-matched placebo. All patients received weekly, individual drug counseling in addition to the monthly injection.

Patients in the two groups receiving BUP-XR achieved abstinence from opioids at a statistically higher rate than the placebo group: 41% for the BUP-XR 300-mg/300-mg group and 43% for the 300-mg/100-mg group, compared with 5% for the placebo group.

“The results of this study further support the utility of extended-release buprenorphine products in the treatment of opioid use disorder,” said Chris Herndon, PharmD, BCACP, FASHP, professor at Southern Illinois University Edwardsville School of Pharmacy.

Headache, constipation, and nausea were the most common adverse events reported, but overall, patients receiving BUP-XR appeared to tolerate it well. According to the study, which was funded by Indivior, the safety profile of BUP-XR was consistent with that of other buprenorphine products except for injection-site reaction, which was reported in more than 5% of all patients who received BUP-XR.

Sarah Melton, PharmD, BCPP, BCACP, FASCP, professor of pharmacy practice at Gatton College of Pharmacy at East Tennessee State University, said results of the BUP-XR trial are consistent with what she’s seen in treatment of moderate to severe opioid use disorder using sublingual buprenorphine-naloxone in combination with substance use disorder counseling, 12-step programs, and other wrap-around services. In general, medication-assisted treatment (MAT) combined with psychosocial support is being viewed more favorably for treatment of patients with opioid use disorder.

Sublingual or buccal buprenorphine-naloxone is currently the most common form of buprenorphine to treat opioid dependence.

Patients who take BUP-XR need to be transitioned to the medication after a minimum of 7 days, after initial treatment with a sublingual buprenorphine-containing product.

In addition, certain buprenorphine products, including BUP-XR, are subject to the requirements of FDA’s Risk Evaluation and Mitigation Strategy (REMS). Only health care providers can prescribe and administer BUP-XR.

“Pharmacists can help patients who are interested in receiving the formulation by identifying prescribers who offer this as part of a comprehensive opioid use disorder treatment program,” said Melton.

To write a prescription for buprenorphine for MAT to treat opioid use disorder, prescribers must have a Drug Addiction Treatment Act (DATA) of 2000 waiver. Herndon said one barrier to receiving this medication is that only a limited number of waivered prescribers are able and willing to provide buprenorphine to treat opioid use disorder.

“Cost and hurdles for approval through third-party payers also makes these products unrealistic for many of the patients who need them the most,” said Herndon.

For the full article, please visit for the June 2019 issue of Pharmacy Today.