Two drugs on the horizon may help curb the opioid epidemic, according to pharmaceutical experts.
Drug manufacturers Braeburn Pharmaceuticals, Inc. and Indivor currently have priority review FDA submissions for physician-administered buprenorphine. The FDA has accepted the manufacturers’ New Drug Applications (NDAs) for opioid use disorder (OUD) therapies:
• Braeburn’s CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with OUD.
• Indivor’s NDA for RBP-6000, an investigational once-monthly injectable buprenorphine in the Atrigel delivery system for the treatment of adults with moderate-to-severe OUD as part of a complete treatment plan to include counseling and psychosocial support.
“Shifting the burden of medication adherence from patients to professional providers in this way could certainly curb the opioid epidemic,” says Jennifer Seagle, PharmD, area clinical manager, CompleteRx.
Depot-based drug delivery isn’t new, but it is new for opioid use disorder treatments. Physician-administered treatment has long been successful at treating other disease states—such as psychological disorders—in which patients have historically struggled with compliance, says Seagle.
“Indivior and Braeburn are very smart to apply this approach to pain management as it will increase both safety and convenience for patients who will now have the option to go see their doctor weekly or monthly, get a shot in the exact intended dose, and go about their lives—greatly reducing their risk of unintentionally misusing the drugs at home, and thus developing a dependency,” she says.
Why these drugs could improve compliance
Buprenorphine therapy is effective for the treatment of opioid dependence; however, issues around compliance with daily administration and problems associated with drug diversion often result in treatment failure or relapse, says Al Medwar, senior vice president of corporate and business development at BioDelivery Sciences (BDSI), which also has a buprenorphine depot injection for OUD in development.
“For managed care executives, more efficient and convenient forms of buprenorphine have the potential to help improve patient outcomes,” Medwar says.
This was BDSI's focus in the development of Bunavail, which uses its bilayer buccal film technology to more efficiently deliver buprenorphine, according to Medwar.
“The future availability of injectable forms of buprenorphine can further help address compliance and the potential for drug misuse or diversion, which could mean better patient outcomes and fewer long-term costs, not to mention that managed care plans can better assure that they are paying for treatments that are used as intended and have the desired outcomes,” he says.
An added bonus
The availability of various formulations of buprenorphine provides practitioners with other tools to help combat opioid addiction, says Medwar.
“Alternative formulations can help healthcare providers select the delivery means with the best chance of success for their individual patients,” Medwar says. “While buprenorphine is important in the treatment of opioid dependence, those same characteristics make it an excellent choice in the treatment of chronic pain, as it is effective in the treatment of pain and has a Schedule III designation by DEA [Drug Enforcement Administration], meaning there is less abuse and addiction potential compared to Schedule II products.”
Seagle questions whether the price point for these products will enable them to be used at scale. “We don’t yet know what the price for these products will be, but typically, depot delivery is more expensive than oral or transdermal patch delivery,” she says.
“Regardless, managed healthcare executives should keep a close eye on products like these, and as more details emerge, weigh any price increases against the possibility for improved compliance to ensure the greatest outcomes for their patients and their organizations,” she says.