Titan Pharma to Present Phase 3 Data of Probuphine at ASAM Annual Conference

-- Titan Pharmaceuticals, Inc.

announced today the presentation of 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 (ASAM) Annual Conference. The data indicates that participants who were clinically stable on sublingual buprenorphine at a dose of 8mg 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 New Drug Application (NDA) is currently under review by the FDA with an action date of May 27, 2016. "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," said co-lead investigator and an author of the presentation Richard N. Rosenthal, M.D., Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. "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 to 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." The poster titled, "A Randomized Trial of Probuphine Implants in Adults Stabilized on Sublingual Buprenorphine," presented data from the double-blind, double-dummy study, which was designed to determine the efficacy and safety of Probuphine as a maintenance treatment for opioid addiction. The primary endpoint was a non-inferiority comparison of the Probuphine and the sublingual buprenorphine treatment arms. As previously reported, the study met its primary endpoint as well as all secondary endpoints, and the treatment was well tolerated by the study subjects. Further details are included in the poster presentation, which was co-authored by Michelle R. Lofwall, M.D., University of Kentucky College of Medicine, Center on Drug and Alcohol Research in Lexington, Kentucky; Sonnie Kim, Ph.D., Braeburn Pharmaceuticals; Katherine L. Beebe, Ph.D., Titan Pharmaceuticals; Michael Chen, Ph.D., TCM Groups, Inc.; and Frank J. Vocci, Ph.D., Friends Research Institute. "We are very pleased to be presenting these important data for the first time at the ASAM meeting and will continue to work closely with our partner, Braeburn Pharmaceuticals, on a broad medical communications strategy for Probuphine, if approved by the FDA," said Kate Beebe, Ph.D., Executive Vice President and Chief Development Officer of Titan Pharmaceuticals. 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 (PDAC), 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.