15 Nov Results from a Phase III Clinical Trial Demonstrate the Success of an Injectable Opioid Dependence Treatment
Braeburn Pharmaceuticals and Camurus AB (STO:CAMX) have announced that they received very positive early outcome findings from their pivotal phase III randomized clinical trial of an injectable treatment for opioid dependency.
Opioid addiction is a rapidly growing epidemic in America. In 2013, the twelve-month and lifetime prevalence of nonmedical prescription opioid use disorder according to the DSM-V were 0.9% and 2.1%, respectively.1 The death tolls from abuse of these substance has increased at an alarming rate. Drug overdose is now the leading cause of accidental death in the US, with fatality rates from overdose exceeding 55,000 in 2015 alone.2 Opioid addiction accounts for a large portion of this toll, with more than 20,000 overdose deaths being related to prescription pain relievers and nearly 13,000 overdose deaths being related to heroin.3 Buprenorphine is an approved medication for treating adult patients with opioid use disorder and has shown much promise in its effectiveness.4
For the phase III randomized, double-blind, active-controlled, parallel group, multi-center, intervention trial, 428 adult patients with an opioid use disorder agreed to participate and were enrolled. The goals of this late phase study were to assess the safety and efficacy of weekly and monthly subcutaneous injections of buprenorphine (CAM2038) for treating adult outpatients with opioid use disorder.
Analysis of the primary outcome data, though it has not yet been published, revealed that CAM2038 achieved statistical non-inferiority when compared to the daily sublingual buprenorphine/naloxone. Moreover, there were very few serious adverse events reported during the study and the two treatment groups demonstrated comparable safety profiles. A full analysis of the outcome data is expected to be released in April 2017.
Given these significant findings, it is likely that CAM2038 injectable buprenorphine products will provide effective new solutions for both patients and physicians. This is particularly important in populations of patients with substance use disorders, given the well know difficulty with treatment compliance and their constantly evolving needs as they progress through the stages of recovery.
In terms of buprenorphine, specifically, the current standard of care involves daily administration of sublingual buprenorphine. Findings from this study demonstrated that once-weekly and once-monthly CAM2038 injectable buprenorphine products are superior for treating adults with opioid use disorder and, together with another recently approved Probuphine 6-month buprenorphine implant, have the power to transform the current treatment for opioid addictions. Moreover, the FDA has been noted as granting an expedited designation to the CAM2038 subcutaneous injection application for release on the market.
1 Saha TD, Kerridge BT, Goldstein RB, Chou SP, Zhang H, Jung J et al. Nonmedical prescription opioid use disorder in the United States. J Clin Psychiatry. 2016;77(6):772-780.
2 Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 1999-2015 on CDC WONDER Online Database. Accessed at http://wonder.cdc.gov/ucd-icd10.html.
3 National Institute on Drug Abuse. Drug Facts: Heroin. 2014; Bethesda, MD: National Institute on Drug Abuse. Accessed at http://www.drugabuse.gov/publications/drugfacts/heroin.
4 Stein BD, Sorbero M, Dick AW et al. Physician capacity to treat opioid use disorder with buprenorphine-assisted treatment. JAMA. 2016;316(11):1211-1212.