FDA Approves First Implantable Device for Opioid Dependency
Titan Pharma Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency
May 27, 2016
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco, California – Titan Pharmaceuticals (TTNP) announced that the U.S. Food and Drug Administration (FDA) approved Probuphine (buprenorphine) implant for long-term maintenance of opioid dependence.
Probuphine is made up of four devices about the size of matchsticks, that are transplanted into a patient’s arm. They dispense buprenorphine, an opioid that treats pain, but also weans patients off dependence on stronger opioids like oxycodone, morphine, and heroin. It can last for up to six months.
“Opioid abuse and addiction have taken a devastating toll on American families,” said Robert Califf, FDA Commissioner, in a statement. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives. Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
Because it requires a minor surgical procedure, specific training is required through a restricted program called the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program. The FDA is calling for postmarketing studies to determine if additional courses of treatment are safe and possible. According to Braeburn Pharmaceuticals, more than 2,200 physicians have already registered for the training programs.
The device currently comes with a black-box warning. Side effects include possible implant migration, protrusion, expulsion and nerve damage. Some physicians have expressed concern that the device may give patients a reason to depend on medication and not participate in the lifestyle changes necessary to break an opioid addiction.
The Probuphine technology was developed by Titan, and is being licensed and commercialized by Braeburn Pharmaceuticals, headquartered in Princeton, New Jersey.
“I believe the world is going towards long-acting medicines anyways,” Behshad Sheldon, chief executive officer of Braeburn, told Fortune. “I know of a couple of big pharma companies, one of which we have a research agreement with, that want to see whether their novel products could be made into a one-year implant. The world will change the way that medicines are delivered.”
The product is only approved currently for patients already stable on low-to-moderate doses of buprenorphine.
The two drugs most used to treat opioid addiction are methadone and buprenorphine. Methadone is only provided by government-endorsed clinics. Buprenorphine is less addictive than methadone, and typically comes as a pill or strip of film.
At the moment pricing for the device has not been released, although Sheldon said it would be significantly less expensive than Vivitrol. Vivitrol is used to treat opioid and alcohol dependence and is manufactured by Dublin-based Alkermes (ALKS). In the U.S., Vivitrol runs about $1,100 per month.
“I intend to make this the most successful implant that’s ever been marketed,” Sheldon told Reuters. “And I think it’s absolutely possible given the unmet need.”
“As a clinician who has treated hundreds of patients for opioid addiction, including as a clinical investigator in the Probuphine studies, I am very encouraged by the prospects of this new treatment,” said Genie Bailey, associate clinical professor of Psychiatry, Brown University and Director of Research, Stanley Street Treatment & Resources in Fall River, Massachusetts, in a statement. “It’s extremely important that patients maintain their addiction treatment once they’ve stabilized on daily dosing of buprenorphine. Probuphine’s method of continuously delivering buprenorphine provides for long-term maintenance and offers the potential for enhances patient compliance and a better quality of life.”