Post-hoc analyses of phase III trial of Buvidal consistent with primary endpoint in opioid-use disorder

Camurus has announced positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase III study of CAM 2038 or Buvidal (buprenorphine prolonged-release solution for subcutaneous injection) for the treatment of opioid dependent patients with evidence of fentanyl use prior to treatment initiation. The results of the post-hoc analyses, consistent with primary and secondary endpoints, indicate that treatment with Buvidal resulted in a greater reduction of fentanyl and overall illicit opioid use in this population compared to treatment with daily sublingual buprenorphine/naloxone, SL BPN/NX. Additionally, there was a trend towards lower withdrawal as measured by the Clinical Opioid Withdrawal Scale (COWS) scores and lower craving score as measured by the Need to Use Visual Analog Scale (VAS) with Buvidal compared to SL BPN/NX in the patents with evidence of fentanyl use.

In the pivotal Phase III study, published in JAMA Internal Medicine in May 2018, Buvidal demonstrated non-inferiority for the proportion of patients with no evidence of illicit opioid use and met superiority on the cumulative distribution function (CDF) for the percent of negative illicit opioid assessments with comparable systemic safety as compared to SL BPN/NX. With the exception of injection site adverse events (AEs), the safety profile observed with Buvidal was consistent with the known safety profile of SL BPN with no unexpected AEs observed. No fatal or non-fatal overdoses were observed for patients treated with Buvidal in the study.

Comment: 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. Buvidal is designed for flexible dosing and is available in four weekly strengths (8mg, 16mg, 24mg and 32mg) and three monthly strengths (64mg, 96mg and 128mg), enabling treatment to be tailored to the patient's individual needs.