- Braeburn Pharmaceuticals
A tiny matchstick-size implant called Probuphine could help address some of the toughest parts of treating addiction.
The implant, an inch long and the width of a matchstick, is designed to deliver the drug buprenorphine to people suffering from opioid painkiller addiction continuously for six months. It’s the first implanted opioid addiction treatment to be approved by the FDA.
Buprenorphine is an opioid that appears to work by activating the receptors in the brain that respond to opiates like prescription pain medications and heroin. It is designed to create a “ceiling effect” over those receptors so that an addicted person doesn’t crave getting high to the same extreme. This would ideally cut down the person’s desire for the drug.
The implant was approved four months after an advisory committee recommended it, but the final decision was delayed three more months to give the agency time to get a more complete picture of its technology and roll-out plan. Part of that plan involves training doctors, Braeburn Pharmaceuticals CEO Behshad Sheldon told Business Insider.
Sheldon said she expects training on how to implant the device to begin as soon as Memorial Day weekend, with the devices launching for use in patients by June 21.
Sticking with treatment
According to the Centers for Disease Control and Prevention, only about half of all people who take any kind of medication do so in the way that’s actually prescribed. About 20% to 30% of people never fill their prescriptions in the first place, and others simply forget to take it or choose not to.
That’s a big problem not only when it comes to chronic diseases, which need constant and consistent management, but in particular with conditions that are pain-related and require treatment with powerful painkillers which can be addictive.
Over time, most people develop a steady tolerance for opioid painkillers, meaning they more of the drug to get the same effect. If they stop taking the medication regularly, that tolerance goes down. This can be dangerous: If an addicted person who’s managed to stop using a drug for a long period of time takes it again, he or she can overdose fairly easily and die. This is what contributes to higher rates of overdose in many addicts, according to the National Institute for Drug Abuse.
This is one of the ideas fueling Braeburn’s implant. “If you make a mistake, because opioid dependence is so unforgiving as a disease, one mistake could kill you,” Sheldon said.
Another concern is that buprenorphine is often misused by people who are not opioid dependent to get high. The hope is that an implant would make that more difficult.
Concerns about cost
The implant won’t necessarily be cheap, though Sheldon said it would be priced lower than other long-acting drugs used in the neuropsychological space. Braeburn is also working with payors to come up with an “outcome-based agreement” that will give them rebates if Probuphine doesn’t save them money, compared to other buprenorphine options.
This is Braeburn’s first drug approval. Beyond that, the company is looking into injectable versions of buprenorphine taken weekly or monthly that could bridge the massive gap between taking a pill once a day and a six-month-long treatment plan. That way, the doctor can better monitor the recovery in its early stages, a concern heard at the advisory committee meeting for the implant.