The Food and Drug Administration has approved the first buprenorphine implant, Probuphine, to treat addiction to both prescription and illegal opioids.
Up to four one-inch-long rods can implanted on the inside of a patient’s upper arm and provide a low-level dose of buprenorphine for six months, as long as a patient has been stable on low to moderate doses of the previously approved tablet or sublingual forms of the medication.
The FDA’s press release said the implant has advantages over the other forms, like the fact it can’t be stolen or sold by others with opioid dependencies and patients can’t run out of medication.
“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” FDA Commissioner Robert M. Califf, MD, said in a statement.
In earlier clinical trials, the FDA said 63 percent of patients with the implant had no evidence of illicit opioid use for the six months the device was delivering buprenorphine, nearly the same as the 64 percent of those taking the under-the-tongue film.
The FDA recommended the implant be used as a part of a broader treatment program, including counseling and "psychosocial support.” The medication does come with side effects, such as implant-site pain, itching and redness, headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain.
Probuphine was developed by California-based Titan Pharmaceuticals, along with marketer Braeburn Pharmaceuticals in New Jersey. Braeburn CEO Behsad Sheldon told the Wall Street Journal that a six-month supply would cost less than $6,000, but declined to specify how much less.
In separate comments to Forbes, Sheldon said the companies have been preparing to quickly train healthcare providers on how to implant and remove Probuphine.
“Approximately 2,250 providers are registered to attend a training session within the six weeks following FDA approval,” Sheldon said. “We have capacity to train up to 3,000 providers within this six-week period. We will have capacity to train a total of 4,000 providers by the end of 2016.”