New long-acting treatment for opioid-use disorders, tested at UK, is one step closer to submission for FDA approval

Clinical trials of a long-acting therapeutic treatment to treat moderate to severe opioid-use disorders were shown to be effective, making the treatment a good contender for submission to the Food and Drug Administration for approval, according to a University of Kentucky news release.

Dr. Michelle Lofwall, holding implantable medication to treat opioid-use disorder. (UK photo)

The trials, led by researchers at UK’s Center on Drug and Alcohol Research, compared the performance of long-acting weekly and monthly buprenorphine therapy, called CAM2038, to the current standard of care, a daily dose of buprenorphine/naloxone, or Suboxone.

Suboxone is a “medication-assisted treatment” for people addicted to heroin or other opiates that acts by blocking the effects of opiates while relieving the symptoms of opiate withdrawal, but it too can be abused.

The trial established that CAM2038 was considered “non-inferior” to the current daily treatment, but a “key secondary outcome” was that the drug was “superior” to current standards of treatment because it couldn’t be used illegally, says the release.

“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,” Dr. Michelle Lofwall, lead researcher, said in the release.

The news release said the weekly injection would be appropriate for induction and initial stabilization of the patient, and the monthly injection would be conducive for stabilized patients. Together, they would allow for “flexible and individualized dosing that is critical for optimal patient outcomes and recovery from a deadly disease.”

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, 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.”

Opioid overdoses cause more than 30,000 deaths every year, and 2.6 million Americans suffer from an opioid-use disorder. Stateline reported in March that Kentucky had the fourth-highest rate of painkiller prescriptions, at about 130 for every 100 people. As of May 2016, Kentucky had 1,248 overdose deaths, up from 1,071 in 2014.

Lofwall, who sees patients struggles with opioid-use disorders in clinical practice, stressed the need for progressive and practical therapies to treat opioid addiction, says the release.

The therapy was developed by Braeburn Pharmaceuticals and Camurus.