Home » FDA has approved opioid abuse treatment implant

FDA has approved opioid abuse treatment implant


On Thursday, May 26, the Federal Drug Administration (FDA) approved Titan Pharmaceuticals’ opioid agonist device Probuphine for implantation in stabilized opioid recovery patients.

This comes four months after the FDA’s advisory committee recommended the implant. Braeburn Pharmaceuticals CEO Behshad Sheldon said training for administering doctors can begin as soon as Memorial Day weekend could be in patients by the end of June. Here’s what else we know so far.

  • The FDA’s Probuphine approval is specifically for patients who have tapered their dependency on buprenorphine down to 8 mg or less daily. This medication for opioid addiction previously came in a sublingual pill and dissolvable film
  • Probuphine will be inserted as a quartet of devices, fanned out subdermally, atop the inner bicep; the procedure takes roughly 15 minutes, and is time-released for six months before being removed or replaced by an authorized doctor
  • Currently, 28,000 doctors are federally authorized to prescribe buprenorphine, but around 6,000 of them write close to 90 percent of the total prescriptions
  • After doctors get certified, they can prescribe Probuphine or the existing buprenorphine forms to 100 patients at a time; however the Obama administration proposed doubling the limit to 200 patients
  • The sustained release of Probuphine targets ever-fluctuating cravings that come with opioids like heroin or powerful prescription painkillers like Percocet or OxyContin

Scott Segal, is the president and chief medical officer of one of the research centers that conducted Probuphine clinical trials. He explains how it works.

“It tends to saturate the receptors that respond to opiates,” Segal said. “Even if you were to take opiates with it, you won’t get high. It provides pain relief, but doesn’t give them the buzz or high that heroin would.”

A solution that should stick

The Centers for Disease Control and Prevention report just half of all people taking medication do so in the way that is prescribed. The CDC also reveals 20–30 percent of people never fill assigned prescriptions in the first place, and still others forget or later decide not to take it.

Annie Umbricht, M.D., is a leading expert in substance abuse treatment at Johns Hopkins University in Baltimore. In speaking of buprenorphine prescriptions being accidentally swallowed by dependents or sold and shared with other opiate users, she states, “Researchers estimate that as much as 50 percent of oral buprenorphine prescriptions are ‘diverted.'”

She affirms the implant treatment will circumvent this problem as well as offer formidable support for those who were seriously addicted to heroin or prescription painkillers. “We know the rate of relapse after drug treatment is more than 90 percent … These people have lost their tolerance, but they don’t realize it. They are at high risk for overdose.”

The Sovereign Health Group is a nationwide leader in rehabilitation from addictions and mental disorders. We use cutting-edge treatment modalities to serving as the embodiment of our motto: “A Better Way to a Better Life.” We offer tailored treatment regimens in our residential, outpatient and partial-hospitalization tracks for lasting rehabilitation. Call our 24/7 helpline to learn more.

About the author

Sovereign Health Group staff writer Kristin Currin-Sheehan is a mindful spirit swimming in metaphysical pools with faith as her compass. Her cover: a 30s-something Cinderella breadwinner of an all-sport blended family. Her repertoire includes writing poetry, lifestyle articles and TV news; editing, radio production and on-camera reporting. For more information and other inquiries about this media, contact the author at news@sovhealth.com.

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