Indivior PLC — Sublocade FDA Review (NDA209819, ORIG 1, 2017)
Indivior PLC · 2017 · FDA Review (openFDA) · company profile →
Report summary
This clinical review evaluates Indivior's Sublocade (buprenorphine extended-release injection) for moderate to severe opioid use disorder (OUD). Proposed as the first once-monthly injectable, Sublocade is intended for use with counseling. Clinical trials, including a pivotal Phase 3 study, demonstrated statistically significant efficacy over placebo in reducing illicit opioid use, with an acceptable safety profile. The recommended dosing is an initial two 300 mg doses followed by 100 mg monthly maintenance, with an option for 300 mg maintenance. Safety concerns include injection site reactions, hepatic effects (dose-dependent), and CNS/respiratory depression. The 300/300 mg regimen showed more adverse events than the 300/100 mg. A REMS program is proposed to mitigate misuse and diversion risks.
Key findings — cited to the page
| Dosing Regimen | 300 mg/month x 2 doses followed by 100 mg/month, with option to increase to 300 mg/month | Sublocade (RBP-6000) · p.2 |
| Buprenorphine plasma concentration for opioid blockade | greater than 2 ng/ml | Sublocade · p.11 |
| PDUFA Goal Date | 11/30/2017 | Sublocade (RBP-6000) · p.2 |
| Proposed Indication | Treatment of moderate to severe opioid use disorder (OUD) in patients who have undergone induction to suppress opioid withdrawal signs and symptoms with a transmucosal buprenorphine-containing product | Sublocade (RBP-6000) · p.2 |
| Buprenorphine sublingual tablet formulation approval year | 2002 | buprenorphine · p.22 |
| Review Priority | Priority Review | Sublocade (RBP-6000) · p.2 |
| Buprenorphine sublingual film formulation approval year | 2010 | buprenorphine · p.22 |
| Buprenorphine parenteral formulation approval year | 1981 | buprenorphine · p.22 |
| Buprenorphine implantable product approval year | 2015 | buprenorphine · p.22 |
| Recommendation on Regulatory Action | Approval | Sublocade (RBP-6000) · p.2 |
| Application Number | 209819 | Sublocade (RBP-6000) · p.2 |
| Number of patients randomized | 504 | Sublocade (RBP-6000) · p.11 |
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 →