Study Supporting Injectable Buprenorphine Reaches Publication

Details of the study that led to the Food and Drug Administration's (FDA's) approval of a monthly injectable form of buprenorphine for opioid dependence are now accessible in a journal publication.

The Lancet has published results of the Phase 3 study involving 200 participants with long-term opioid addiction. Extended-release buprenorphine injections administered in two different dosage strengths resulted in significant improvement compared with placebo in controlling drug craving, facilitating abstinence from opioids and relieving withdrawal symptoms.

Treatment retention for participants receiving the injectable buprenorphine was also twice as high as that for participants receiving placebo. All study participants received weekly individual counseling in addition to the medication.

Extended-release buprenorphine patients received either six monthly injections of 300 mg or two injections of 300 mg and four injections of 100 mg. Headache, constipation and nausea were the most common adverse events associated with the study drug, the researchers reported.

The FDA in November 2017 approved an extended-release formulation of buprenorphine marketed as Sublocade, but at the time of approval the full details of the supporting research were not publicly available. Other available formulations designed to improve adherence and treatment retention over daily dosing of buprenorphine include a six-month subcutaneous formulation marketed as Probuphine.