New data on weekly and monthly buprenorphine injections for treating opioid dependence in fentanyl users

LUND, Sweden, June 25, 2024 — Camurus, a biopharmaceutical company focused on long-acting medicines for severe and chronic conditions, has released new findings from a 24-week Phase 3 clinical trial. These findings, published in JAMA Network Open, illustrate the effectiveness of weekly and monthly subcutaneous (SC) buprenorphine injections (Buvidal®/Brixadi®) in treating individuals with opioid dependence, particularly those using fentanyl. This post hoc analysis supports the results from the initial Phase 3 study.

The study assessed 428 participants, with 123 individuals identified as using fentanyl at the study's baseline (64 in the SC-BPN group, 59 in the SL-BPN/NX group). The results demonstrated a higher mean percentage of urine samples negative for fentanyl in the SC-BPN group (74%) compared to the SL-BPN/NX group (61.9%). Additionally, withdrawal symptoms and cravings showed significant reductions following the initiation of the treatment in participants who were fentanyl-positive at the beginning of the study. Completion rates were similar between fentanyl-positive (60.2%) and fentanyl-negative (56.7%) participants. The safety profile for SC-BPN was consistent with established safety data for buprenorphine, apart from mild to moderate injection site reactions.

Dr. Edward V. Nunes, Professor of Psychiatry at Columbia University Irving Medical Center, emphasized that these findings align with previous data, showcasing the potential of extended-release buprenorphine as an effective treatment for opioid dependence, including in those using fentanyl. This is especially relevant as the fentanyl crisis continues to pose significant public health challenges in the United States.

Fredrik Tiberg, President and CEO of Camurus, noted that the unique data set collected during the fentanyl crisis underscores the efficacy of weekly and monthly subcutaneous buprenorphine injections in treating opioid dependence. This treatment option could provide a significant advantage for healthcare providers managing patients with opioid use disorders, particularly those involving fentanyl.

Buvidal® (buprenorphine prolonged-release solution) is designed for subcutaneous injection in prefilled syringes and is indicated for the treatment of opioid dependence within a comprehensive framework of medical, social, and psychological support. It is approved for use in adults and adolescents aged 16 years and older and is available in various strengths to allow for tailored treatment plans. Administration by healthcare professionals aims to enhance treatment adherence and reduce risks associated with diversion, misuse, and accidental pediatric exposure.

Camurus is a Swedish company dedicated to developing innovative, long-acting medicines utilizing its proprietary FluidCrystal® drug delivery technologies. The company's clinical pipeline includes treatments for dependence, pain, cancer, and endocrine disorders, developed both in-house and through collaborations with global pharmaceutical companies. Camurus' shares are traded on Nasdaq Stockholm under the ticker CAMX.