Friday, May 27, 2016
The U.S. Food and Drug Administration approved a drug-emitting arm implant to treat addiction to heroin and other opioids, providing a new tool against a condition that has proved extraordinarily difficult to manage.
Some addiction experts said the implant could offer a more reliable way to keep addicts on their medication. But like all drugs meant to treat drug addiction, the device could face opposition from those who embrace the total-sobriety approach to treatment long advocated by 12-step programs.
Despite a new push by the Obama administration and many public-health officials to promote medication for opioid addiction, some treatment centers still shun or discourage it.
The match-stick-size implant, called Probuphine, emits buprenorphine, a drug that eases cravings for opioids and prevents withdrawal symptoms. Four implants are inserted into the upper arm at a time, providing six months’ worth of drug.
Behshad Sheldon, chief executive of the implant’s marketer, Braeburn Pharmaceuticals, said Probuphine would cost less than $6,000 for a six-month supply. She declined to be more specific. Titan Pharmaceuticals Inc. co-developed the device with Braeburn, and will receive royalties on sales.
Buprenorphine is already available in tablet form, or as films that dissolve in the mouth, but addicts sometimes run out of doses, or skip them and use illegal narcotics instead. Some also sell their buprenorphine to other addicts.
The implant makes this behavior impossible, and so has won support from some addiction experts.
“For someone with an opioid-use disorder, they have to decide on a daily basis if they’re going to take their buprenorphine,” says Marvin Seppala, chief medical officer of Hazelden Betty Ford Foundation, a nonprofit treatment provider. “That decision every day to remain abstinent from opioids is difficult. The implant takes away that decision.”
Public-health officials say better treatment is desperately needed to fight the growing epidemic of opioid abuse. More than 47,000 Americans died of drug overdoses in 2014—a record that exceeded the number killed in car accidents, according to the Centers for Disease Control and Prevention. The biggest drivers of those deaths were opioid painkillers and heroin.
The FDA approved Probuphine’s use in people who are already stable on a low or moderate dose of oral buprenorphine. The agency said Probuphine should be used alongside counseling and other “psychosocial support.” Health-care providers must complete a training program on inserting the implants before they will become certified to administer them, the FDA said.
A recent clinical study tested the implant in 175 people who had already been taking an oral form of buprenorphine for six months. Half continued to take oral doses and the other half received Probuphine; both groups received 10 urine tests over six months, to screen for illicit opioids.
The study, financed by Braeburn Pharmaceuticals, found that rates of illicit opioid use were no worse in the Probuphine group than in the oral buprenorphine group, according to results summarized in FDA documents.
The most common side effects of Probuphine include pain, itching and redness at the implant site, as well as headache, depression and other issues, the FDA said.
The three main types of medication for opioid addiction all interact with the same parts of the brain that illicit opioids do. Methadone, like heroin, is a full opioid agonist that activates the brain’s opioid receptors, but it is a slower-acting drug that staves off withdrawal without producing the same euphoric rush. Buprenorphine is a partial agonist that blocks cravings and withdrawal symptoms but doesn’t typically cause euphoria in people accustomed to heroin, doctors say. Naltrexone is an opioid antagonist that blocks the opioid receptors so they can’t be activated to produce a high.
“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid-use disorder than short-term detoxification programs aimed at abstinence,” Nora Volkow, director of the National Institute on Drug Abuse, said in a statement Thursday.
Such evidence has convinced many treatment providers to start incorporating medication into rehab programs. In 2012, Hazelden Betty Ford Foundation started recommending medication to opioid addicts after many decades of promoting abstinence treatment, said Dr. Seppala.
But persistent stigma about medication means not all patients have, or want, access to it. Many “are told by family members or judges or other health-care providers that taking a medication for part of their treatment is somehow substituting one addiction for another, that they aren’t totally in recovery or they aren’t ‘clean,’ ” says Yngvild Olsen, who chairs the public policy committee at the American Society of Addiction Medicine.
Mina Kalfas, a physician in northern Kentucky who uses medication to treat opioid addiction, says a number of rehab centers in the region still offer only abstinence-based treatment.
Source : wsj.com
