In a comeback win, FDA OKs Titan’s implanted drug for opioid addicts

Clinicians looking for a reliable, controlled method to treat a host of recovering opioid addicts will now have a new resource in the armamentarium. The FDA has approved Probuphine, a small implanted device about the size of a matchstick that dispenses a low-level dose of buprenorphine over 6 months.

Buprenorphine has long been a mainstay treatment for opioid dependence, but the pills and films used to provide the drug can be lost, stolen or sold. They can also be forgotten, which also won’t be a problem for an implanted dispenser which is surgically inserted into the arm.

Braeburn Pharmaceuticals landed the commercial rights to the new therapy, which was developed by Titan Pharmaceuticals. Developers aimed at a maintenance dose targeting opioid receptors at the brain, helping reduce addict’s cravings while tamping down on the effects of withdrawal.

The approval marks a major turnaround for Titan, which was spurned by the FDA almost exactly three years ago. Even though a majority of its expert panel members voted in favor of marketing the drug/device at the time, the agency demanded better evidence that a significant number of patients using the implant would actually be free of opioid use. They also wanted more data on proper dosing.

The approval lands as an epidemic of opioid abuse once more becomes a spotlight public health issue in the U.S.

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. Physicians who implant these devices are asked to follow up regularly with their patients.

“We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Dr. Robert Califf in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.” 

- here's the release