FDA panel greenlights Probuphine for opioid addiction

FDA advisors recommended approval of the first long-acting, subdermal buprenorphine implant (Probuphine, Titan Pharmaceuticals, Inc. and Braeburn Pharmaceuticals) for the maintenance treatment of opioid addiction.

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Opioids, when taken as prescribed, can be used to manage pain safely and effectively. However, regular or long-term use or abuse of opioids can lead to physical dependence, and in some cases, addiction. There are approximately 2.5 million Americans who suffer from opioid addiction, with approximately 80% of this population being addicted to prescription opioids, such as oxycodone, hydrocodone, and codeine. Consequences of this abuse include respiratory depression, brain damage, and unintentional overdose deaths.

Buprenorphine is the active ingredient in multiple FDA-approved products for the treatment of opioid dependence. It is an opioid analgesic that acts as a partial mu agonist, meaning its analgesic effects plateau at higher doses and it then behaves like an antagonist. Buprenorphine is currently available in tablet and film formulations that require daily dosing. Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for 6 months following a single treatment. It was developed using ProNeura, Titan Pharmaceutical’s continuous drug delivery system, and is placed subdermally, normally in the upper arm, in an outpatient office procedure.

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The Psychopharmacologic Drugs Advisory Committee (PDAC) of FDA voted 12 to 5 in favor of approving Probuphine for the maintenance treatment of opioid addiction in stable patients receiving 8 mg or less per day of buprenorphine. The vote followed Braeburn Pharmaceutical’s presentation of results of the most recent clinical trial confirming the efficacy of Probuphine along with sensitivity analyses to evaluate the strength of the results. The manufacturer also presented safety findings pertaining to the insertion and removal procedures for the implantable drug.

"New treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and we appreciate the Committee's comprehensive review of Probuphine," said Titan Pharmaceuticals President and CEO Sunil Bhonsle, in a press release. "Probuphine has the potential to be the first marketed product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. As a subdermal implant, Probuphine could increase patient compliance, decrease the risk of diversion and improve patients' quality of life. We look forward to the Agency completing its review of the NDA."

A target agency action date has been set for February 27, 2016. FDA is not obligated to follow the recommendations of its Advisory Committee, but will consider the Committee's recommendation as it completes its review of the Probuphine NDA.

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