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Buprenorphine depot formulations effective for opioid use disorder

Long-acting subcutaneous depot buprenorphine formulations conferred more opioid-negative urine samples and a better response rate among adults with opioid use disorder than sublingual buprenorphine-naloxone, according to a new study published in JAMA Internal Medicine.

“Buprenorphine treatment for opioid use disorder may be improved by sustained-release formulations,” Michelle R. Lofwall, MD, from the Center on Drug and Alcohol Research at the University of Kentucky, and colleagues wrote.

Lofwall and colleagues conducted a randomized clinical trial to compare the efficacy of weekly and monthly subcutaneous buprenorphine depot formulations with a daily sublingual combination of buprenorphine hydrochloride and naloxone hydrochloride for treating opioid use disorder.

The researchers enrolled 428 adults with moderate-to-severe opioid use disorder (61.4% men; mean age, 38.4 years) and randomly assigned 215 to receive daily sublingual buprenorphine-naloxone and matched weekly and monthly subcutaneous placebo injections and 213 to receive daily sublingual placebo and weekly and monthly subcutaneous buprenorphine.

Results showed a 3% difference (95% CI, –4 to 9.9) in response rates between the sublingual buprenorphine-naloxone group (14.4%) and the subcutaneous buprenorphine group (17.4%). Opioid-negative urine samples were observed in 28.4% of patients in the sublingual buprenorphine-naloxone group and 35.1% of those in the subcutaneous buprenorphine group (6.7% difference; 95% CI, –0.1 to 13.6).

Evidence for no illicit opioid use, as measured by a cumulative distribution function, was statistically superior among patients in the subcutaneous buprenorphine group, compared with those in the sublingual buprenorphine-naloxone group. Approximately 22% of participants in the sublingual buprenorphine-naloxone group demonstrated signs of injection site adverse events, as did about 19% of those in the subcutaneous buprenorphine group. No adverse events were severe.

“These results support the efficacy of long-acting weekly and monthly subcutaneous depot buprenorphine formulations as an additional [opioid use disorder] treatment option,” Lofwall and colleagues concluded. “These formulations may also address potential limitations and concerns about daily dosing, including diversion, misuse and accidental exposure of medication to children.” – by Alaina Tedesco

Disclosure: Lofwall reports receiving research funding from Braeburn Pharmaceuticals, Inc., and consulting fees from Braeburn Pharmaceuticals, Inc., and Indivior. Please see study for all other authors’ relevant financial disclosures.