The randomized, double-blind clinical trial compared weekly and monthly dosage of CAM2038, a buprenorphine therapy developed by Braeburn Pharmaceuticals and Camurus, with the current standard of care: a daily dose of buprenorphine/naloxone.
Reaching a milestone for FDA approval
Led by Dr. Michelle Lofwall in UK’s CDAR, the trial established the drug’s non-inferiority to the current treatment, a critical milestone in the application for FDA approval. While results indicated CAM2038 met non-inferiority, a key secondary outcome also demonstrated that CAM2038 was superior to current standard treatment, based on a pre-defined distribution of illicit opioid use.
Opioid overdoses cause more than 30,000 deaths every year, and 2.6 million Americans suffer from an opioid use disorder. More than 12 million people misused a prescription opioid pain reliever and 800,000 used heroin in 2015. The National Institutes on Drug Abuse has called for safe, proven solutions to initiate treatment and stabilize patients through an extended opioid recovery program. The Surgeon General’s Report called for more access to evidence-based effective treatments, like buprenorphine, for opioid use disorders.
The study’s positive results provided the necessary evidence for entering the FDA-approval submission process. Evidence suggests people with a moderate-to-severe opioid use disorder might benefit from receiving an injectable therapy administered on a weekly or monthly basis. The weekly injection is appropriate for induction and initial stabilization, and the monthly injection is better for stabilized patients. Together, both weekly and monthly medications allow for individualized dosing, which is critical for optimal patient outcomes and recovery from a deadly disease.
Lofwall, a psychiatrist and associate professor in the UK College of Medicine, served as principal investigator on the study, along with Sharon Walsh, director of the CDAR. Lofwall, who sees patients’ personal struggles with opioid use disorder in clinical practice, stresses the need for progressive and practical therapies to treat opioid addiction. An injectable therapy administered in a clinician’s office eliminates the risk of diverting traditional forms of buprenorphine and decreases the risk of relapse and overdose. The discreet nature of the therapy also eliminates any stigma and shame felt by patients taking oral opioid maintenance medications in daily life.
“If approved, the CAM2038 weekly and monthly injectable buprenorphine medications can improve how we treat opioid addiction and decrease the stigma associated with the medication that is in large part due to concerns about non-adherence and diversion,” Lofwall said. “Together with the six-month buprenorphine implant, these new long-acting medication delivery systems would allow us to administer a proven medication to the patients directly, leading to improved medication efficacy as demonstrated in this trial as well as avoiding the potential for missed or stolen doses, diversion or accidental pediatric exposure, which are significant public health concerns.”
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges.