Camurus announced the publication in JAMA Network Open of a new post hoc analysis from a 24-week randomized, double-blind, Phase 3 study comparing weekly and monthly subcutaneous (SC) buprenorphine injections (Buvidal®?/Brixadi®?) to daily sublingual buprenorphine/naloxone (SL-BPN/NX). The data presented suggests the effectiveness in individuals with opioid dependence who use fentanyl, consistent with the results from the Phase 3 study. Of 428 trial participants, 123 (SC-BPN, n=64; SL-BPN/NX, n=59) had evidence of baseline fentanyl use.

In the fentanyl-positive subgroup, the mean percentage of urine samples negative for fentanyl during the study was 74% for the SC-BPN arm versus 61.9% for the SL BPN/NX arm). Withdrawal symptoms and cravings decreased following treatment initiation in patients positive for fentanyl use at baseline. No substantial difference was observed in rates of study completion between fentanyl-positive and fentanyl-negative cohorts (60.2% and 56.7%, respectively).

The safety profile of SC-BPN was comparable to the known safety profile of buprenorphine, with the exception of mild to moderate injection site reactions. Buvidal (buprenorphine prolonged-release solution for subcutaneous injection in prefilled syringe) is indicated for the treatment of opioid dependence within a framework of medical, social, and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.3Buvidal is available in four weekly strengths (8mg, 16mg, 24mg and 32mg) and four monthly strengths (64mg, 96mg, 128mg and 160mg), enabling treatment to be tailored to the patient's individual needs.

Administration of Buvidal is restricted to healthcare professionals, with the potential of increasing treatment compliance, and minimizing risks of diversion, misuse, and paediatric exposure. Buvidal is approved for treatment of opioid dependence in the EU, UK, Switzerland, Australia, New Zealand and several countries in the Middle East and North Africa. In the US, the product is available under the tradename Brixadi through Camurus licensee Braeburn.