Until now, treatment with buprenorphine has been based on taking pills or dissolvable film. The implant, called Probuphine, is intended for people who are already stable on low doses of the drug.
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Currently, opioid addiction is predominantly treated with one of 2 options: methadone and buprenorphine.
The implant makes this behavior impossible, and therefore has won support from some addiction experts.
The director of the National Institute on Drug Abuse said drugs like Probuphine could be “more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence”. The Obama administration made clear its intent to intensify the war on opioid addiction, recently issuing an urgent call to big-pharma to focus greater efforts on making anti-addiction drugs more available, while at the same time making opioids and opioid substitutes more hard for addicts to use.
Regulators are also intensely aware of the potential for abuse if an addict decides to extract the implant for the stock of buprenorphine it carries.
Behshad Sheldon, chief executive of the drug’s maker, Braeburn Pharmaceuticals Inc., said Probuphine would cost less than $6,000 for a six-month supply.
The arm gets this device implanted, and it discharges a steady dose of the medication buprenorphine, which was previous available only in the form of pill, to limit opioid cravings and stops withdrawal symptoms over half a year.
A matchstick-size arm implant called Probuphine has been approved by the U.S. Food and Drug Administration to treat addiction to opioids, such as heroin and OxyContin, providing new hope for the fight against a condition that is very hard to manage.
Probuphine is a subdermal implant, made by Titan Pharmaceuticals and Braeburn Pharmaceuticals, which continuously delivers a low-level dose of buprenorphine for up to six months.
“Opioid abuse and addiction have taken a devastating toll on American families”, said Dr. Robert M. Califf, FDA commissioner.
And almost 86 percent of the people who used Probuphine in the trial managed to stay off illicit opioids for the entire six months, which was nearly 14 percentage points better than the group that used oral versions containing buprenorphine.
Two million Americans were dependent on prescription opioids in 2014, when the most recent data was available, federal statistics show.
Amid an epidemic of opioid addiction, its possible approval has touched off an intense debate. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder”, she said in the release.
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The most common side effects from treatment with Probuphine include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. Health-care providers need to complete a training program on how to insert the implants before they can be certified to administer them. Clinical studies of Probuphine did not include participants over the age of 65. 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 the 12-step community. The FDA rejected it in 2013 because they said that the dosing would be too low to provide effective treatment.
