The Food and Drug Administration (FDA) approved the first-ever implant to fight opioid abuse last week, offering hope amid an epidemic that killed nearly half a million Americans between 2000 and 2015. But some addiction experts are arguing that making the implant commercially available is premature, as questions remain over whether it would do more harm than good.
The matchstick-size implant, Probuphine, was developed by Braeburn Pharmaceuticals and Titan Pharmaceuticals, and is designed to release buprenorphine over a period of six months.
Buprenorphine is used to treat opioid dependence including narcotic painkillers and heroin. It's part of a class of medications called opioid partial agonist-antagonists and works to prevent withdrawal symptoms when someone stops taking opiod drugs by producing similar effects to these drugs.
Probuphine developers say the rod-like device is designed to make the drug less susceptible to abuse or illicit resale, which is a common issue with oral drugs currently on the market. However, Probuphine’s four rods must be surgically implanted into a patient’s arm, and that’s just one area where Dr. Indra Cidambi, an addiction expert and detox specialist, sees problems arising.
“Doctors of osteotherapy, internists and psychiatrists are three-fourths of the prescribers,” Cidambi told FoxNews.com. “That means these are the offices which don’t have a setup to perform a minor surgical procedure.”
This barrier brings a divided-care component into play, raising questions over which doctor will be responsible for overseeing the patient’s care, she said.
“It should be that the prescriber and implanter are in the same office, but it’s difficult to get two doctors in the office in the same time frame,” Cidambi said.
In a statement following the FDA's approval, president and CEO of Braeburn Pharmamaceuticals Behshad Sheldon said the company's top priorities are to train and certify healthcare providers to make Probuphine available to patients across the country. Currently there are 121 physicians certified to both prescribe and implant Probuphine, with training in 55 cities planned over the next six weeks.
Another concern is whether patients will continue with psychiatric care and lifestyle changes after receiving the implant, Cidambi said. Patients prescribed oral buprenorphine may be prone to mixing the drug with another opioid obtained illegally to achieve a high, but therapy can help dissuade patients from taking part in such behavior.
“When you mix buprenorphine with opioids, there is an increased risk of respiratory depression. That’s what you see when a parent goes into a child’s room and they’re not audible,” Cidambi said. “When someone is on these four rods, they’re not following therapy— they’re easily combining the drugs, and that can lead to death.”
Patients may also forget the drug is helping them achieve their sobriety, leaving them under the false impression that they don’t need to attend therapy or adjust their lifestyle changes. In turn, rather than addressing the problem, the device could lead to co-abuse and eventually relapse after the six-month period of Probuphine ends, Cidambi said.
However, Sheldon told FoxNews.com that the medication's labeling does idicate that behavior therapy is recommended, and that there is a policy in place regarding coverage for a patient that requires a physician to indicate that the patient has complied with recommendations for additional care.
According to the Centers for Human and Health Services, fewer than half of the estimated 2.2 million Americans who need treatment for opioid abuse are receiving help. Those who are receiving care are typically prescribed either methadone, which is available only in government-endorsed clinics, or buprenorphine, which is available as a pill or a strip of film. Probuphine works to release 8 milligrams of buprenorphine, which means potential candidates would need to require a low dose.
“It’s really for those doing well on buprenorphine and don’t need a high dose,” Dr. Adam Gordon, a professor of medicine at the University of Pittsburgh and member of the advisory panel who voted in favor of approving Probuphine, told NPR in January. “Will they need to be on it six more months, maybe many times over their entire life? When is a good time to stop treatment? These are unanswered questions.”
Cidambi also questioned the removal process. She cited a simulation study in which doctors were required to remove all four rods, which had been placed in a model patient with different levels of difficulty. For example, one rod was glued, one was broken and one was implanted in such a way that the trainee would have to order imaging. Despite following proper procedure, only seven of 15 participating surgeons successfully removed all four rods.
“I’m not saying that they shouldn’t come up with a new medication to address the problem, but we need to be more practical,” Cidambi said. “Every medication has its pros and cons. I’m questioning, why complicate it more than what it is right now?”
Despite concerns from experts like Cidambi, Sheldon told Reuters ahead of the device’s FDA approval that the company has high hopes for the implant.
“I intend to make this the most successful implant that’s ever been marketed … and I think it’s absolutely possible given the unmet need,” Sheldon said.
The company is aiming to implant a patient with Probuphine by June 21.
Reuters contributed to this report.