Indivior PLC — Sublocade FDA Review (NDA209819, ORIG 1, 2017)
Indivior PLC · 2017 · FDA Review (openFDA) · company profile →
Report summary
This statistical review of Indivior's NDA 209-819 for Sublocade (buprenorphine controlled release injection) for moderate to severe opioid use disorder concludes that the drug demonstrated superiority over placebo. The pivotal Phase 3 study (RB-US-13-0001) showed similar efficacy between the 100 mg and 300 mg dose regimens, supported by sensitivity analyses and secondary endpoints like COWS, SOWS, and opioid craving VAS. An advisory committee voted 18 to 1 for approval, and the review team is currently assessing the overall benefit-risk profile.
Key findings — cited to the page
| number of phase 3 efficacy studies | single | RBP-6000 · p.19 |
| PDUFA Date | November 30, 2017 | Sublocade · p.2 |
| Phase | 3 | RBP-6000 (Sublocade) · p.6 |
| Trial Design | randomized, double-blind, placebo-controlled, multicenter | RBP-6000 (Sublocade) · p.6 |
| Superiority over placebo (100 mg regimen) | superior | RBP-6000 (Sublocade) · p.6 |
| Superiority over placebo (300 mg regimen) | superior | RBP-6000 (Sublocade) · p.6 |
| Advisory Committee Vote for Approval | 18 to 1 | Sublocade · p.6 |
| Advisory Committee Vote for Approval | 18 to 1 | Sublocade · p.7 |
| Number of randomized subjects | 504 | RBP-6000 (Sublocade) · p.10 |
| Number of subjects randomized to placebo | 100 | RBP-6000 (Sublocade) · p.10 |
| Number of subjects randomized to RBP-6000 100 mg | 203 | RBP-6000 (Sublocade) · p.10 |
| Number of subjects randomized to RBP-6000 300 mg | 201 | RBP-6000 (Sublocade) · p.10 |
Source: Indivior PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →