The implant, which has four matchstick-size rods that are inserted under the skin of the upper arm, administers the anti-addiction drug buprenorphine in a continuous dose for six months. That medication is available now only as a daily pill or a thin film that dissolves under the tongue. The implant, called Probuphine, is intended for people who are already stable on low doses of the drug.
Amid an epidemic of opioid addiction, the implant has touched off an intense debate. Supporters say it will be a helpful addition to the nation’s limited toolbox of treatments, while critics warn that it remains largely unproven and could carry a hefty price tag.
Maryland psychiatrist David Pickar, who sits on the FDA advisory committee that in January voted 12 to 5 to recommend approval, applauded Thursday’s action as the right move.
“It's not a perfect drug, but it has advantages over previous treatments. Number one, it takes away the problem of the patient not taking the medication,” which he said is a “huge” issue when treatment depends on addicts remembering to take their medication daily. With the implant, “they will know that it will be with them for six months.”
In addition, the implant essentially is “a drug that can’t be abused,” meaning that accidental ingestion by children or illegal resale on the street are no longer worries.
“I bet this saves some people’s lives,” Pickar said.
But some, including former advisory committee chair Judith Kramer, a professor emeritus of medicine at the Duke University School of Medicine, had argued against approval. Kramer said the implant’s clinical trial data did not prove it is safe and effective. She noted that even some trial participants needed supplemental buprenorphine for relief, which suggested that the implant dose was too low and that it would be tough to eliminate pills altogether.
The FDA decision comes as the country struggles with an opioid problem of such epic proportions that health experts, public officials and families are desperate for even incremental advances. Deaths from opioid overdoses — involving both prescription narcotics and illicit street drugs, such as heroin — reached a record 28,647 in 2014, according to the Centers for Disease Control and Prevention. Overdoses from all forms of drugs now kill more Americans than car accidents or firearms.
Nora Volkow, director of the National Institute on Drug Abuse, focused on the evidence that suggests maintenance therapies with medication — such as the new implant — plus behavioral treatment and other support are more effective than short-term detox programs aimed at abstinence. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder,” she said in the FDA news release.
Richard Rosenthal, the investigator who helped lead the implant’s clinical trial, said Probuphine’s value is in providing a steady level of medication in the bloodstream, allowing an individual to avoid the peaks and troughs that can increase cravings and the risk of relapse. Rosenthal, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai, pointed to trial results that showed that a substantially higher percentage of people on the implant managed to stay off illicit opioids for the entire six months of the trial, compared with those on oral versions of the drug.
Some comments by the implant’s manufacturer have stirred concern that it will be pricey. Behshad Sheldon, chief executive of Braeburn Pharmaceuticals, declined by email to say how much Probuphine will cost, but said it will be priced “lower than other long-acting medications currently on the market.” That could be a reference to Vivitrol, an injectable form of the anti-addiction drug naltrexone that costs more than $1,000 a month.
Sheldon said the company is exploring “value-based reimbursement programs” to provide insurers with rebates if the overall cost of care for a group of patients on Probuphine exceeded the cost of treatment either for the same patients in a prior six-month period or for a comparable group of patients taking other forms of buprenorphine or other anti-addiction medication.
Doctors will be required to undergo special training on how to insert and remove the implant. About 2,250 health-care providers already have signed up for training, according to Sheldon.
In Jacksonville, Fla., Sarah Wilson was hoping for Probuphine’s approval. The mother of four became addicted to painkillers in 2008 after she suffered serious spinal injuries when her car was hit by a drunk driver. She subsequently lost her job and health insurance and was unable to afford expensive steroid injections. So her doctor began prescribing hydrocodone for pain relief, she said.
Before long, Wilson was dependent on that drug, taking higher and higher doses. She bought pills from other people and stole from her parents to pay for them. Then she enrolled in a clinical trial for buprenorphine, which reduced her cravings and eased her back pain. She also participated in the implant’s trial and testified before the FDA advisory committee in January.
“It was great, not having to worry about taking a pill every day,” said Wilson, 40, whose travel expenses to the hearing were paid by Braeburn. She expects to go back on Probuphine and probably stay on it indefinitely.
Amy Ellis Nutt contributed to this report.