An advisory committee will vote Tuesday on whether to recommend the Food and Drug Administration approve an implant designed to reduce addicts’ cravings for heroin or prescription painkillers.
The implant, probuphine, provides a steady dose of a medication called buprenorphine, which has been shown to ease withdrawal symptoms, decrease cravings and cut the risk of relapse. Probuphine’s manufacturer, New Jersey-based BraeburnPharmaceuticals, says it has the potential to eliminate risks associated with pills or dissolvable strips.
The drug’s development comes at a time when addiction to opiates — drugs such as heroin and morphine and prescription painkillers such as OxyContin andVicodin — has been called an epidemic.
The death rate from drug overdoses more than doubled from 1999 to 2013, according to the Centers for Disease Control and Prevention. Drug overdoses now kill 44,000 Americans a year – more than car accidents.
Medications that treat addiction are strictly regulated to reduce the risk of abuse. Methadone is available only at specialized clinics, where patients typically must go every day to receive a dose. Buprenorphine is considered safer than methadone, because it’s less likely to cause an overdose, and patients can receive buprenorphine at a doctor’s office. Physicians who prescribe buprenorphine must be certified to dispense it and are only allowed to treat 100 patients at a time. About 1 million people took buprenorphine in 2012, according to the FDA.
The White House recommended expanding the use of medications that treat opiate addiction. Addicts who are given such “medication-assisted treatment” cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration. The medications also halve a person’s risk of becoming infected with HIV, the virus that causes AIDS.
Still, buprenorphine pills and film strips carry risks. Buprenorphine is currently available as a pill or a strip that dissolves when placed under the tongue. Critics note addicts sometimes sell their pills or strips to get money to buy other drugs. Like all pills, buprenorphine can be accidentally swallowed by children.
Probuphine aims to avoid such problems. Four tiny rods, each smaller than a match stick, provide a steady amount of medication for up to 6 months. The FDA is considering approving it for a specific population: “stable” patients who are already taking the dissolvable buprenorphine film at a low dose.
Braeburn presented a study of 177 patients to apply for approval.
In the study, doctors compared the use of probuphine implants and buprenorphine film, said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, who spoke at Tuesday’s advisory committee hearing. 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.
Some addiction specialists say that probuphine may not be as safe as its manufacturer suggests.
Doctors don’t 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 4 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 and few were studied for more than 6 months.
“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.”
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, Sheldon said.
Implanting probuphine takes 10 to 15 minutes and removing it takes about 20 minutes, said Steven Chavoustie, a physician involved in a clinical trial of the device.
A DRUG FOR A DRUG…. WOW
“Drug overdoses now kill 44,000 Americans a year – more than car accidents.”
Way more than guns, too.
Ban drugs.
Come on #1, ban drugs, cars and everything inherently dangerous because people are careless? You see where that argument goes?
Or we could simply BAN the so-called ‘government’.
Actually, that makes far more sense.
Agreed. I don’t have a government myself, just a “pretend” one.
Naturally, I was being facetious (as usual) again, Millard. 🙄
I don’t recognize the criminals in office as “my” government. I don’t have one at the moment.
A duly elected Sheriff is the only authority I will recognize. City pigs, alphabet soup agencies, are not recognized. They’re invisible, and I’d sure hate to have to point that out. But that’s the case. They have no authority.
And that F’N Sheriff better be straight up.