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).
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.
For more information call (877) 782-6966 or visit Indivior.com.