A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

Summary

Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.

Timeline

Start

2010-04

Primary completion

2011-05

Completion

2011-05

Outcome

Met primary endpoint

paper The BI CDF was significantly different from placebo (P < 0.0001). PMID 23919595 ↗

release “the 163-patient trial, which showed that patients receiving Titan's Probuphine implant had significantly less illicit opioid use” titanpharm.com ↗

release “The study results were clinically meaningful and statistically significant as demonstrated by two primary analyses, which both confirmed the efficacy of Probuphine compared to placebo” titanpharm.com ↗

release “a confirmatory study of 287 patients that showed statistically significant efficacy versus placebo and non-inferiority with a currently marketed sublingual formulation of buprenorphine” titanpharm.com ↗

release “final Phase 3 trial of Probuphine® for the long-term maintenance treatment of opioid dependence. The trial met all primary and secondary efficacy endpoints” titanpharm.com ↗

Publications

• Rosenthal RN, Ling W, Casadonte P, Vocci F, Bailey GL, Kampman K, Patkar A, Chavoustie S, Blasey C, Sigmon S, Beebe KL. Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone. Addiction. 2013 Dec;108(12):2141-9. doi: 10.1111/add.12315. Epub 2013 Sep 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	12 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	16 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	80 mg	Subcutaneous

Indications