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

Rhea-AI Summary

Camurus has announced a new publication in JAMA Network Open, detailing a post hoc analysis from a 24-week Phase 3 study comparing weekly and monthly subcutaneous buprenorphine injections (Buvidal®/Brixadi®) to daily sublingual buprenorphine/naloxone. The study involved 428 participants, with 123 showing baseline fentanyl use. Results showed that the mean percentage of fentanyl-negative urine samples was higher in the SC-BPN group (74%) compared to the SL-BPN/NX group (61.9%). Withdrawal symptoms and cravings decreased in fentanyl-positive patients following treatment initiation. Safety profiles were consistent with known data, with mild to moderate injection site reactions observed. The publication underscores the effectiveness of extended-release buprenorphine in treating opioid dependence even in patients using fentanyl.

Positive

• The study showed that 74% of urine samples in the SC-BPN group were fentanyl-negative, compared to 61.9% in the SL-BPN/NX group.
• Withdrawal symptoms and cravings decreased for fentanyl-positive patients following treatment initiation.
• The safety profile for SC-BPN was consistent with known buprenorphine safety data, with only mild to moderate injection site reactions.

Negative

• None.

Medical Research Analyst

The latest publication in JAMA Network Open brings attention to the ongoing battle against opioid dependence, especially among individuals using fentanyl. This post hoc analysis provides compelling evidence that weekly and monthly subcutaneous (SC) buprenorphine injections (Buvidal®/Brixadi®) are effective alternatives to the daily sublingual buprenorphine/naloxone (SL-BPN/NX) regimen.

The standout finding is the higher mean percentage of urine samples negative for fentanyl during the study: 74% for SC-BPN versus 61.9% for SL-BPN/NX. This suggests that extended-release buprenorphine injections can potentially offer a more stable and effective solution for opioid dependence, particularly in fentanyl users. Notably, the study also highlights that withdrawal symptoms and cravings were significantly reduced in patients who were fentanyl-positive at baseline.

From a medical perspective, these results are promising since fentanyl dependence is notoriously difficult to treat due to its high potency and the risk of overdose. The comparable safety profile of SC-BPN to traditional buprenorphine treatments, with only mild to moderate injection site reactions reported, further underscores the potential for these injections to become a preferred treatment option. The extended-release formulation may improve adherence and outcomes by reducing the need for daily dosing.

These findings could significantly impact clinical practices and treatment protocols for opioid dependence, suggesting a shift towards favoring extended-release formulations. For investors, this underscores the innovative nature and strong potential of Camurus' pharmaceutical developments.

Market Research Analyst

The publication's data points to a potentially transformative impact on the market for opioid dependence treatments. Camurus' extended-release formulations, Buvidal® and Brixadi®, showing significant efficacy in patients using fentanyl, may drive increased market adoption. The fact that 74% of urine samples in the SC-BPN arm were fentanyl-free compared to 61.9% in the SL-BPN/NX arm indicates a superior performance that can be marketed to both clinicians and patients.

For Camurus, these results could bolster market confidence and attract more investment, considering the increasing focus on effective opioid dependence treatments amid the ongoing opioid crisis. Investors need to look at the potential for these drugs to capture a larger market share, especially given the limitations and challenges associated with daily treatment regimens. The extended-release nature of these formulations offers a clear value proposition in terms of patient compliance and convenience, potentially leading to better treatment outcomes and higher patient retention rates.

The study also highlights an important safety profile, with no major adverse effects reported apart from mild to moderate injection site reactions. This could ease regulatory pathways and increase the likelihood of wider adoption and insurance coverage. Camurus' existing standing in the market, combined with these promising study outcomes, positions it well for growth, thus making it a point of interest for retail investors.

LUND, Sweden, June 25, 2024 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) 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). 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.

The full publication "Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder with Fentanyl Use" is available online at JAMA Network Open today.²

For more information
Fredrik Tiberg, CEO & Head of R&D
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com

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.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.

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. For more information, visit www.camurus.com.

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. doi:10.1001/jamainternmed.2018.1052.
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. doi10.1001/jamanetworkopen.2024.17377. 
3. SmPC Buvidal, Aug 2023

This information was submitted for publication at 5:00 pm CET on 25 June 2024.

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SOURCE Camurus AB

FAQ

What was the outcome of the study comparing SC-BPN and SL-BPN/NX for opioid dependence?

The study showed that 74% of urine samples in the SC-BPN group were fentanyl-negative compared to 61.9% in the SL-BPN/NX group, indicating higher effectiveness for SC-BPN.

What percentage of participants had baseline fentanyl use in the Phase 3 study on buprenorphine?

Out of 428 participants, 123 showed evidence of baseline fentanyl use.

How did SC-BPN affect withdrawal symptoms and cravings in fentanyl-positive patients?

The study found that withdrawal symptoms and cravings decreased following treatment initiation with SC-BPN in fentanyl-positive patients.

Were there any safety concerns with SC-BPN in the Phase 3 study?

The safety profile for SC-BPN was consistent with known buprenorphine data, with only mild to moderate injection site reactions observed.