Titan Pharmaceuticals (NASDAQ:TTNP) has presented data from the last Phase 3 study of Probuphine, a six month subdermal buprenorphine implant for the long-term maintenance treatment of opioid addiction, at a poster session during the 47th Annual American Society of Addiction Medicine Annual Conference.
The data indicate that participants who were clinically stable on sublingual buprenorphine at a dose of 8 mg or less per day maintained stability when transferred to Probuphine, and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine.
The Probuphine NDA is currently under review by the FDA with an action date of May 27.
“This was the first head-to-head comparison study of Probuphine and sublingual buprenorphine, demonstrating the efficacy of a long-acting, six month buprenorphine implant,” Dr. Richard Rosenthal, a co-lead investigator and an author of the presentation, said in a statement.
Dr. Rosenthal, a Prof. of psychiatry and medical director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai, said the study results show that participants in the implant group sustained clinical stability over the course of six months.
The implant group was also more likely to remain free from illicit opioids at 85.7%, compared with 71.9% of those maintained on sublingual buprenorphine. “If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option,” he added.
Probuphine was developed using Titan’s proprietary platform technology, ProNeura, a non-biodegradable drug delivery implant designed to provide continuous, long-term steady state levels of medication in the blood.
In January 2016, the FDA reviewed the Probuphine NDA at a meeting of the Psychopharmacologic Drugs Advisory Committee, and following a discussion of the data presented, the committee voted 12-5 in favor of approval of Probuphine.
If approved by the FDA, Probuphine would be the first marketed product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure.