Injectable Buprenorphine Moves Closer To FDA Approval

By Kelly Burch 01/27/17

The medication-assisted treatment for opioid addiction was given fast-track designation by the FDA in 2015. 

Doctor preparing injection.

A new medication for treating moderate-to-severe opioid addiction is moving toward FDA approval after proving effective in clinical trials. 

The injection, CAM2038, is a buprenorphine shot that is given on either a weekly or monthly basis. Manufacturers and researchers are hopeful that the shot will offer a more effective form of opioid therapy while also increasing adherence to treatment. According to the research team, CAM2038 was shown to be "superior to current standard treatment" for opioid addiction.

"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," said Michelle Lofwall, psychiatrist and associate professor in the UK College of Medicine, who led the study. 

"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, ensuring adherence, 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," said Lofwall, according to Medical Xpress.

In 2015, the FDA gave CAM2038 fast-track designation, which makes it eligible for accelerated approval. 

“The CAM2038 suite of products offers a potential paradigm shift for treating opioid addiction: precise delivery of medicine while virtually eliminating the risks of diversion, abuse, misuse, and accidental pediatric exposure,” Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals said at the time. “The sense of urgency to address the opioid epidemic in our country is overwhelming. Granting fast track to the CAM2038 development program demonstrates the FDA’s recognition of the unmet need in this area as well as the agency’s leadership in enabling new opportunities to stem the tide of opioid addiction.”

In November, Surgeon General Vivek Murthy called for more use of medication-assisted treatment (MAT) options in his report on alcohol, drugs and health. “Abundant scientific data show that long-term use of maintenance medications successfully reduces substance use, risk of relapse and overdose, associated criminal behavior, and transmission of infectious disease, as well as helps patients return to a healthy, functional life,” the report says. 

Last year the FDA approved Probuphine, an implant that delivers a steady dose of buprenorphine for six months. Approving Probuphine for patients is part of the FDA's efforts to support those seeking to "maintain treatment as part of their overall recovery program," FDA Commissioner Dr. Robert M. Califf said at the time. 

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.