New publication shows effectiveness data for weekly and monthly buprenorphine injections in treating opioid dependence in individuals using fentanyl

LUND, Sweden, June 25, 2024. Camurus today announced the publication in JAMA Network Open of a new post hoc analysis from a 24-week randomized, double-blind, Phase 3 study¹ 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.

“These findings are consistent with the Phase 3 data showing the effectiveness of extended-release buprenorphine in addressing opioid dependence, including among patients using fentanyl”, says Edward V. Nunes, M.D., Professor of Psychiatry, Columbia University Irving Medical Center, Department of Psychiatry, NY, US. “Our research highlights its potential to offer an effective treatment for individuals grappling with dependence on opioids.”

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).² 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

“The publication features a unique data set collected during the wake of the fentanyl crisis in the US and suggests that buprenorphine, in particular weekly and monthly subcutaneous injections, is effective in treating opioid dependence including in patients who use fentanyl”, says Fredrik Tiberg, President and CEO at Camurus.

About Buvidal

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.³ Buvidal 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.

About Camurus

Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of dependence, pain, cancer and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX.

References

1. Lofwall, MR, et al. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(6):764-773. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2681061
2. Nunes, E. V., et al. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder with Fentanyl Use. JAMA Network Open. 2024;7(6):e2417377. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820306.
3. SmPC Buvidal, Aug 2023

Posted: June 2024

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Brixadi (buprenorphine) FDA Approval History

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