Adverse events were similar between the groups. The most common were injection-site pain, headache, constipation, nausea, and injection-site pruritus and erythema. Injection-site reactions were mild to moderate.
As a secondary outcome, the cumulative distribution function (CDF) in the subcutaneous buprenorphine depot group was statistically superior to the CDF found in the sublingual buprenorphine with naloxone in the percentage of opioid-negative results. “Cumulative distribution function values are an established endpoint used in early placebo-controlled, phase 3 clinical trials for OUD treatment,” Dr. Lofall and her associates wrote.
The study findings were limited by several factors, including an absence of assessment of patient adherence to sublingual medication and an inability to assess effectiveness vs. efficacy. However, the large size and diverse study population strengthen the results, which support the use of subcutaneous depot buprenorphine formulations for patients with OUD, the researchers noted.
“These formulations may also address potential limitations and concerns about daily dosing, including diversion, misuse, and accidental exposure of medication to children,” they said.
The study was supported in part by Braeburn Pharmaceuticals and the University of Kentucky, Lexington. Dr. Lofwall disclosed research funding and consulting fees from Braeburn Pharmaceuticals and Indivior.
SOURCE: Lofwall M et al. JAMA Intern Med. 2018 May 14. doi: 10.1001/jamainternmed.2018.1052.