Four tiny, implantable rods that steadily ooze drugs could help some patients kick opioid addictions, an advisory committee for the Food and Drug Administration concluded Tuesday . With a 12 to 5 vote, the committee of medical experts recommended that the regulatory agency approve the implantable device for use—and the agency often follows such advice.
If approved, the treatment would debut amid a national epidemic of addictions and overdoses involving opioids, which includes prescription painkillers and heroin. The committee concluded that the implantable device could offer a safer way to deliver medication-based treatments for addicts, who desperately need better options. However, dissenting members of the committee expressed concern over the device’s safety and hinted that the need to address the addiction epidemic may have clouded the committee’s judgment.
“We all desperately want something to be available,” the committee’s acting chairwoman Judith Kramer told USA Today after the committee’s Tuesday vote. But, she said, “I’m very concerned about the precedent this sets.” Kramer, a professor emerita at Duke University, was one of the five dissenting committee members.
The implantable device being discussed, called probuphine, is composed of four metal rods, each smaller than a match stick. The rods seep buprenorphine, a semisynthetic opioid that eases withdrawal symptoms, lessens cravings, and cuts relapse risks in recovering opioid addicts.
While buprenorphine is already one of the most commonly used medications to treat opioid addictions, the current oral forms are easy to abuse. Patients can overdose on the drug or sell it for money to buy heroin or other opioids. For this reason, drug-based treatments for addiction have to be strictly regulated. For instance, methadone, another opioid that’s used to treat opioid addiction, is only available at specialized clinics and patients are often only given a day’s dose at a time.
With the implantable probuphine, made by New Jersey-based Braeburn Pharmaceuticals, patients would get a consistent, fixed stream of the drug.
“I think this will save some folks’ lives,” said committee member David Pickar, adjunct professor of psychiatry at Johns Hopkins Medical School, who voted to recommend approval. “From a safety point of view I think we’re in good shape.”
But not everyone agrees. The implant only lasts for six months, while many patients need to stay on the drug treatments for years. It’s unclear what happens after six months, Kramer said.
Also, the committee acknowledged that it’s very common to adjust the dosage of buprenorphine, particularly during the start of a patient’s treatment. That would mean doctors might have to prescribe supplemental oral doses to patients who already have an implant, which would negate the purpose of the implant. It’s also unclear how to transition patients from taking oral doses to relying on the implant.
On the other hand, experts were concerned that patients content with just the implant may be less inclined to show up for clinical check-ins and necessary counseling.
Listing image by Braeburn Pharmaceuticals
