Luke Winkie, Motherboard by Vice
November 15, 2016[…]
Probuphine isn’t a drug as much as it’s a novel way to administer treatment. In a 15-minute in-office visit, a doctor will insert four white, tube-like flexible implants into a patient’s upper arm. Those implants are each the size of a matchstick and will drip-feed Buprenorphine directly into the bloodstream and up to the brain. The drug will then fasten onto the same neural receptors triggered by heroin or prescription narcotic painkiller use, effectively curbing one’s desire to get high. The implants will be replaced every six months. Think of it like a microscopic IV with no physical traces. The convenience is the primary perk—Probuphine patients don’t have to worry about remembering their pills or refilling their prescriptions. […]
Probuphine can only be prescribed to those who’ve already successfully been on traditional Buprenorphine treatment in order to make sure patients aren’t rushed to mismatched treatment. But the promise is still intriguing. Probuphine was featured in a double-blind, double-dummy phase III clinical trial earlier this year. The trials were overseen by Dr. Richard Rosenthal, a psychiatrist at New York’s Mt. Sinai Hospital, who told CBS Evening News that what excites him most about Probuphine is that it’s “a new weapon in our armamentarium to fight drug addiction.”
“The risk of relapse is reduced,” he added, “because you’re not going to miss a dose.”
Braeburn Pharmaceuticals, the company that manufactures Probuphine, reported “significant superiority for the implant versus the oral formulation” during the trials. The Food and Drug Administration approved the drug in May.
Behshad Sheldon, CEO of Braeburn Pharmaceuticals, told me implant-based medicine could be applied to any chronic condition that requires daily maintenance.
“We have heard of people who use Probuphine to protect them from their future selves,” Sheldon said. “They might think, ‘Right now I’m really determined to not use, but in three days I might slip up. It’s easier if I had to make the choice to take the medicine to not take it.’ There are people who use this medication who like that idea.”
Anyone who’s ever been on long-term medication knows how difficult it can be to stay disciplined between side effects, scheduling, and the loose, wax-and-wane bell curve of the therapeutic duration. But what if, someday, the very concept of a daily prescription becomes a thing of the past? […]
Sheldon said that there are already implant products for people with schizophrenia, depression, and bipolar disorder. According to Sheldon this is where the industry is headed.
“I do think this is the wave of the future,” Sheldon said. “A lot pharma companies are looking [at implants] for things even beyond mental health like long-term infections. There’s even one looking at an implant for diabetes.”
But others aren’t as convinced about the treatment’s efficacy and safety. Diana Zuckerman is a former post-doctoral fellow at Yale Medical School and currently serves as the president of the Washington, DC-based think tank The National Center of Health Research, which recently noted gaps in Probuphine’s trials.
“I think the big issue is the transition,” said Zuckerman, who was not involved with the trials. “People are going to go from taking pills to using this implant. The implant doesn’t work immediately. It takes a while for it to work and settle into the level that it’s supposed to be. And during that time the person is still going to be taking pills, and that becomes a vulnerable time. How many pills should that person take before the implant is really working, and should they continue to take pills after it’s working?“
According to Zuckerman, medical companies rarely have the motivation to do research once a treatment has been approved by the FDA. At the end of the day, her main concern is that a subdermal implant like Probuphine treats opioid addicts with more opioids.
“Obviously we’ve got a huge problem in this country, and we’ve got to find a way, and I think step number one is to prevent people from becoming addicted by having doctors not prescribe [opioids] so loosely,” Zuckerman said. “But step number two is finding out a better way to help people once they’re addicted. We don’t seem to have a good handle on that.”
The National Institute on Drug Abuse estimates that some 2.1 million Americans are dependent on prescription opioids like Percocet and Oxycontin. The Center for Disease Control has called it an epidemic. […]
It can be easy to categorize the US opioid epidemic in a seedy, faraway place where good morals and prudence will always conquer. But opioid dependency finds everyday people. Probuphine is making the disease easier for some of those addicts to live with, but treatment, which costs an estimated $6000 per six-month session, is only one part of recovery. […]
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