Indivior Publishes Phase 3 Data on Buprenorphine Extended-Release

Indivior PLC (LON: INDV) announced that data from its pivotal phase 3 clinical trial evaluating the efficacy, safety and tolerability of SUBLOCADETM (buprenorphine extended-release) injection for subcutaneous use (CIII), were published by The Lancet. The 24-week trial met its primary and key secondary endpoints for both the 300/300 mg and 300/100 mg dosage regimens of SUBLOCADE, which demonstrated clinically and statistically significant differences in percentage abstinence from opioid use based on negative urine samples and self-reports of illicit drug use as well as treatment success defined as participants with =80% opioid abstinence during weeks 5-24, compared to placebo1.

“Findings show that SUBLOCADE administered by healthcare providers delivered sustained buprenorphine exposure for the entire monthly period while increasing abstinence rates and controlling craving and withdrawal symptoms for patients in this pivotal trial, compared to placebo. This represents an effective option in the treatment of opioid use disorder,” said Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior. “We are proud of the potential impact that these data represent for patients on their path to recovery from opioid use disorder and our continuing efforts to partner with the treatment community.”

The manuscript, published on February 18, 2019 in The Lancet, is titled “Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.” This phase 3 study served as one of the key studies from the clinical development program that supported the U.S. Food and Drug Administration (FDA) approval of SUBLOCADE in November 2017.

https://www.marketscreener.com/INDIVIOR-19344116/news/The-Lancet-Publishes-Phase-3-Results-Demonstrating-Efficacy-Safety-and-Tolerability-of-SUBLOCADE-tr-28096386/