Sublocade(Buprenorphine)

Sublocade (buprenorphine) is a parenteral formulation of buprenorphine, approved in 2017 under Application Number 209819 with a Priority Review. Buprenorphine has been available in various formulations since 1981, including sublingual tablets (2002) and sublingual films (2010), with an implantable product approved in 2015. The regulatory recommendation for Sublocade was Approval, with a PDUFA Goal Date of 11/30/2017.

In a 24-week pivotal efficacy study involving 504 randomized patients, Sublocade demonstrated a treatment success rate (responder) of 28%-29%. This represented an increase of approximately 20% compared to placebo. The percentage of patients achieving 100% negative drug use assessments was 12-13%. For the RBP-6000 100 mg regimen, the cumulative percentage of 100% negative opioid use was 13%, and for the RBP-6000 300 mg regimen, it was 12%, compared to 1% for placebo. The P-value for the difference between RBP-6000 dosing regimens and placebo was <0.0001. A buprenorphine plasma concentration greater than 2 ng/ml was associated with opioid blockade.

Safety data included 66.6% of subjects receiving more than 6 injections of RBP-6000, and 43.3% receiving 12 injections. Exposure to RBP-6000 for more than 24 weeks was observed in 63.9% of subjects, and for more than 48 weeks in 37.7% of subjects.