Sometime in the next two months the Food and Drug Administration is
expected to decide whether to give the go-ahead for an implant designed
to treat addiction to heroin or prescription painkillers. Known as
Probuphine, the implant releases medication that helps prevent
withdrawal and reduces cravings over the course of six months.
An FDA advisory committee voted 12-5 to recommend its approval. But the product has raised some safety concerns.
The development of Probuphine comes at a time when the White House, along with health organizations, are recommending the expanded use of medications to treat opiate addiction. The most effective medications are methadone and buprenorphine, commonly known as Suboxone. Both cut the risk of death from overdose in half and substantially reduce infections from IV drug use such as HIV and hepatitis C, according to the Substance Abuse and Mental Health Services Administration.
Probuphine, says Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, delivers a steady dose of buprenorphine through four matchstick-size implants in a patient’s arm.
“I think long-acting products are a game changer in almost every therapeutic area,” she says. “I think they’re absolutely a game changer when it comes to opioid use disorder. I am confident Probuphine itself is going to help a lot of patients. We’ve had patients say that it changes their lives.”
Probuphine is specifically intended for patients who have been taking buprenorphine successfully for awhile. And Sheldon, whose company is manufacturing the implant, says it has several advantages over buprenorphine pills or films that patients dissolve under the tongue.
No. 1 is that it helps patients stay compliant with treatment. They don’t have to worry about forgetting to take the medication.
“There’s also no possibility of losing your medication or having it stolen or having it accidentally taken by children,” Sheldon says. “The medication doesn’t end up on the street.”
Diversion
has been an unintended consequence of medication-assisted treatment, as
some addicts buy the drugs on the street in an effort to stave off
withdrawal, and others sell their medication to buy other drugs.
Despite the potential advantages of a long-acting maintenance medication for addiction, there are concerns about the safety of Probuphine. Addiction specialist Dr. Mark Publicker, who has a Portland-based Suboxone practice, says he’s wary of the fact that an FDA advisory committee recommended approval based on what’s known as an “open label” study funded by the drug company.
“What that means is both the patient and the researcher were aware as to whether or not they were implanted with the active medicine or with a placebo.” he says.
Dr. Publicker says that knowledge can distort study results since there’s a real desire to demonstrate the effectiveness of the drug. He also has concerns about what might happen to someone with the implant in an emergency where surgery or anesthesia becomes necessary.
“Just in terms of, would somebody treating a person in an emergency room actually know that the person had this device or know how to remove it?” he says.
Insertion of Probuphine under the skin takes about 15 minutes. Removal takes a little longer. And if it’s approved by the FDA, doctors will have to be trained on how to do both.
What concerns pharmacist Tracy Rupp is the transition of buprenorphine patients to the implant, which takes three or four weeks to kick in at a therapeutic level.
Rupp is with the National Center for Health Research which analyzes health information. She says taking buprenorphine by mouth may still be necessary for awhile.
“You have this risk where you have patients who are previously stable and then you subject them to this window period where they’re not really covered at all,” she says. “They could easily overdose or die during that window period.”
Some addiction specialists have said they don’t think Probuphine has been studied long enough to justify FDA approval.
But at a public hearing on Probuphine in January, patients, doctors and clinical trial investigators urged its approval. They pointed to the clinical study indicating that at end of six months, 85 percent of patients given Probuphine showed no evidence of illicit drug use compared to 72 percent of patients on the oral form of buprenorphine.
An FDA advisory committee voted 12-5 to recommend its approval. But the product has raised some safety concerns.
The development of Probuphine comes at a time when the White House, along with health organizations, are recommending the expanded use of medications to treat opiate addiction. The most effective medications are methadone and buprenorphine, commonly known as Suboxone. Both cut the risk of death from overdose in half and substantially reduce infections from IV drug use such as HIV and hepatitis C, according to the Substance Abuse and Mental Health Services Administration.
Probuphine, says Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, delivers a steady dose of buprenorphine through four matchstick-size implants in a patient’s arm.
“I think long-acting products are a game changer in almost every therapeutic area,” she says. “I think they’re absolutely a game changer when it comes to opioid use disorder. I am confident Probuphine itself is going to help a lot of patients. We’ve had patients say that it changes their lives.”
Probuphine is specifically intended for patients who have been taking buprenorphine successfully for awhile. And Sheldon, whose company is manufacturing the implant, says it has several advantages over buprenorphine pills or films that patients dissolve under the tongue.
No. 1 is that it helps patients stay compliant with treatment. They don’t have to worry about forgetting to take the medication.
“There’s also no possibility of losing your medication or having it stolen or having it accidentally taken by children,” Sheldon says. “The medication doesn’t end up on the street.”
Despite the potential advantages of a long-acting maintenance medication for addiction, there are concerns about the safety of Probuphine. Addiction specialist Dr. Mark Publicker, who has a Portland-based Suboxone practice, says he’s wary of the fact that an FDA advisory committee recommended approval based on what’s known as an “open label” study funded by the drug company.
“What that means is both the patient and the researcher were aware as to whether or not they were implanted with the active medicine or with a placebo.” he says.
Dr. Publicker says that knowledge can distort study results since there’s a real desire to demonstrate the effectiveness of the drug. He also has concerns about what might happen to someone with the implant in an emergency where surgery or anesthesia becomes necessary.
“Just in terms of, would somebody treating a person in an emergency room actually know that the person had this device or know how to remove it?” he says.
Insertion of Probuphine under the skin takes about 15 minutes. Removal takes a little longer. And if it’s approved by the FDA, doctors will have to be trained on how to do both.
What concerns pharmacist Tracy Rupp is the transition of buprenorphine patients to the implant, which takes three or four weeks to kick in at a therapeutic level.
Rupp is with the National Center for Health Research which analyzes health information. She says taking buprenorphine by mouth may still be necessary for awhile.
“You have this risk where you have patients who are previously stable and then you subject them to this window period where they’re not really covered at all,” she says. “They could easily overdose or die during that window period.”
Some addiction specialists have said they don’t think Probuphine has been studied long enough to justify FDA approval.
But at a public hearing on Probuphine in January, patients, doctors and clinical trial investigators urged its approval. They pointed to the clinical study indicating that at end of six months, 85 percent of patients given Probuphine showed no evidence of illicit drug use compared to 72 percent of patients on the oral form of buprenorphine.
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