1. Could the availability of alternatives to sublingual buprenorphine prove as revolutionary as the introduction of buprenorphine itself? Phase 3 study results for weekly and monthly injections of Braeburn Pharmaceuticals and Camurus's CAM2038 showed not only non-inferiority to the sublingual medication, but CAM2038 outperformed it on negative urine tests for opioids in combination with patient self-reports.
2. The Food and Drug Administration (FDA) has granted Fast Track designation for the CAM2038 products, and New Drug Applications are expected to be submitted by the middle of this year. Some patients could be initiated directly to the weekly injection.
3. Injectable formulations theoretically can work in conjunction with Probuphine, the six-month buprenorphine implant approved in 2016. Patients stabilized on an injectable could graduate to the longer-lasting implant.
4. Michelle Lofwall, MD, of the University of Kentucky Center on Drug and Alcohol Research, the 428-patient Phase 3 study's primary investigator, says injectables could improve treatment adherence and reduce stigma in communities where payers remain concerned about buprenorphine diversion. “They give patients an opportunity for a better quality of life,” she says. “They don't have to worry about forgetting their medication.”
5. What factors could stymie progress? “A lot will depend on what happens with the Affordable Care Act,” Lofwall says. “If it is dismantled, and parity doesn't exist, many patients won't have access.”