The approval mirrors an Obama administration priority to make anti-addiction drugs more available.
The device is implanted in the arm and releases a steady dose of the medication buprenorphine, which before had only been available as a pill, to curtail opioid cravings and prevent withdrawal symptoms over six months.
"Opioid abuse and addiction have taken a devastating toll on American families," said Dr. Robert M. Califf, commissioner of the FDA, when the announcement was made Thursday. "We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives."
The approval of the device, named Probuphine, "provides the first-ever implantable option" to help patients maintain treatment addiction, Califf said. Advocates said because it is implanted it will ensure patients do not miss their daily dose nor sell their supply to recreational users or other addicts.
The treatment still may fuel controversy from those who favor abstinence treatment and consider anti-addiction drugs substituting one drug for another.
But the FDA views expanding medication-assisted treatment, currently, methadone, buprenorphine or naltrexone, as a cornerstone of its plan to decrease opioid overdose, death and dependence from heroin and opioids such as hydrocodone and oxycodone.
"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," said Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health.
Addiction growing more deadly
Two million Americans were dependent on prescription opioids in 2014, when the most recent data was available, federal statistics show.
Overdoses linked to opioids killed more than 28,000 people nationwide two years ago, according to the Centers for Disease Control and Prevention. The deaths include those involving heroin and prescription drugs such as oxycodone and hydrocodone.
Every 19 minutes, someone dies from an accidental overdose, the CDC reports.
Americans represent just 5 percent of the world's population, but they consume 80% of the world's opioids, according to the American Society of Interventional Pain Physicians.
Most drug overdose deaths -- at least six out of 10 -- involve an opioid, federal statistics show.
"Overdose deaths involving prescription opioids have quadrupled since 1999, and so have sales of these prescription drugs," the CDC says.
Lately, much of the talk about opioid addiction has been centered on the difficulty in getting treatment. Critics say one of the hamstrings in treatment is limited access to buprenorphine -- brand name Suboxone. Prescriptions to buprenorphine are limited by the federal law because of concern of it ending up in nonpatient hands through trafficking on the black market.
Suboxone can be abused because it can be taken in the way to provide the same feeling of euphoria as opioids.
"Suboxone is an opioid medication," said Dr. Adam Bisaga, professor of psychiatry at CUMC and researcher at New York State Psychiatric Institute who works closely with heroin addicts. "It can be misused. Some use it intravenously, they inject it, and they have lost control over the medication and are truly addicted. But that's really a small portion of patients. All the evidence shows that this is small."
Probuphine is supposed to deal with the diversion and overuse issues because it is implanted. As with other anti-addiction drugs, it is to be used in conjunction with behavioral treatment to help manage an addict's recovery and ease withdrawal from opioid drugs.
Profits for developers Braeburn Pharmaceuticals and Titan Pharmaceuticals could be intense, with the six-month treatment reportedly running about $6,000.