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# FDA Panel Backs Probuphine Implant for Opioid Cravings
- URL: https://www.fdaweb.com/fda-panel-backs-probuphine-implant-for-opioid-cravings/
- Published: 2016-01-12T12:00:00.000Z
- Updated: 2026-09-15T02:26:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134416

> FDA’s Psychopharmacologic Drugs Advisory Committee has voted 12 to 5 to recommend approval for a Titan Pharmaceuticals NDA for the probuphine implant that is designed to reduce cravings in opioid dependent patients. The agency noted that as an implantable formulation, probuphine is intended to be difficult to divert or abuse, and less likely than sublingual buprenorphine formulations to be accidentally ingested by small children. It also offers the possibility of improved adherence to treatment and improved patient convenience.  
>  
> An FDA [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM480732.pdf?ref=fdaweb.com) noted that the product presents a novel safety concern among products used to treat opioid dependence associated with the surgical insertion and subsequent need to remove the implanted rods. It is similar to the now-withdrawn Norplant contraceptive. “Despite the fact that insertion and removal of Norplant were performed by providers trained in surgery, the product’s safety experience identified the potential for various insertion and removal-related complications, some of them with disabling consequences,” the agency said. “Similar difficulties may be anticipated with Probuphine, perhaps further complicated by the population of both prescribers who generally lack surgical training and patients who present more heterogeneity in age, sex, and health status compared to the population being treated with Norplant.”  
>  
> Titan has proposed a training program for providers, and a closed distribution system to ensure the insertion and removal procedures are performed only by trained providers.