An advisory committee recommended Tuesday that the Food and Drug Administration (FDA) approve an implant designed to reduce addicts’ cravings for heroin or prescription painkillers.
The implant, probuphine, provides a steady dose of buprenorphine, which has been shown to ease withdrawal symptoms, decrease cravings and cut the risk of relapse. Buprenorphine is currently available only as a pill or dissolvable film that’s placed under the tongue. Although it can be life-saving, it carries major risks: some addicts sell their supplies to get money for other drugs. […]
Doctors who want to prescribe probuphine would have to refer patients to providers trained to implant medical devices, or undergo training to learn how to safely implant and remove it, said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, who spoke at Tuesday’s advisory committee hearing. […]
Pharmacist Tracy Rupp urged the committee to reject probuphine, noting that its manufacturer presented only one clinical study showing the drug was effective.
In the study, doctors compared the use of probuphine implants and buprenorphine film, Sheldon said. Patients in the study were considered “stable” because they had been safely using the films. After 6 months, 85% of those given probuphine tested negative for illegal drugs, compared to 72% of those given the film.
The study had multiple flaws, said Rupp, director of public health policy initiatives at the National Center for Health Research, a nonpartisan group that analyzes health data.
Some missing urine tests were counted as negative, as if the patient had no drugs in their system. But Rupp noted that people addicted to opiates “often skip tests to avoid a positive test.” That could skew the results, Rupp said.
“It is disappointing that the advisory committee set such a low bar for safety and effectiveness,” Rupp said after the vote. “Is probuphine effective? We still don’t know because the study was poorly designed and missing data.” […]
Some addiction specialists say they’re concerned about probuphine’s safety.
Doctors don’t yet know how to safely transition patients from buprenorphine films to the implant, said pharmacist Tracy Rupp, director of public health policy initiatives at the National Center for Health Research, a nonpartisan group that analyzes health data.
Rupp, who recommended the committee reject probuphine, said it takes up to four weeks for the implant to provide the same level of medication provided by the film strips. That suggests patients will need to continue taking buprenorphine by mouth for the first few weeks after receiving the implant, Rupp said.
Rupp said she’s worried patients could relapse during that transition. “This is an unacceptable risk for stable patients,” Rupp said.
Rupp also said the study didn’t match the demographics of addicts in real life, noting 84% of the patients in the study were white. Jennifer Higgins, the committee’s acting consumer representative, said she would like the FDA to require studies in more diverse populations.
“This is not the real world of opioid addiction,” Rupp said. “Many of these patients will require treatment for years. We need long-term safety data from diverse populations. Patients will require a new incision every 6 months, creating an ongoing risk of harm due to bleeding and infectious complications.”
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