Indivior announced positive top-line results from the Phase 3 clinical trial of RBP-6000 (buprenorphine monthly depot) for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.

The Phase 3 study was a multicenter, randomized, double-blind, placebo-controlled trial evaluating RBP-6000 in 489 patients with moderate or severe opioid use disorder currently untreated but seeking medication-assisted treatment. Patients initially received Suboxone (buprenorphine/naloxone) sublingual film for 3 days for opiate withdrawal prevention, and then completed a 4- to 11-day Suboxone dose adjustment (8mg–24mg). After achieving no significant opioid craving (≤20mm on the Opioid Craving Visual Analog Scale [VAS]) or withdrawal (a score of ≤ 12 on the Clinical Opiate Withdrawal Scale [COWS]) after at least 7 days of Suboxone, patients were randomized to receive placebo or 1 of 2 RBP-6000 regimens: RBP-6000 300mg on Day 1 then every 28 days thereafter (5 injections), or RBP-6000 300mg on Day 1 and 29, followed by 100mg every 28 days (4 injections). 

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The primary endpoint of the study was the cumulative distribution function (CDF) of the percentage of urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from Week 5 through Week 24. Secondary endpoint included treatment success, defined as any subject with ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use from Week 5 through Week 24.

The study met both the primary and secondary endpoints, demonstrating significant efficacy for either dosing regimens of RBP-6000 compared to placebo (P<0.0001 for both endpoints and regimens). Additionally, RBP-6000 was found to be generally well-tolerated. Patients who experienced a serious treatment-emergent adverse event (TEAE) included 2.8% from the RBP-6000 treatment groups vs. 5.1% in the placebo group. Complete data analysis from this study is currently ongoing.

RBP-6000 is an investigational, subcutaneous, sustained-release formulation of buprenorphine, utilizing the ATRIGEL delivery system for long-acting monthly depot injection.

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