Titan Pharmaceuticals (NASDAQ: TTNP) is presenting data today from four post hoc sensitivity analyses of the final Phase 3 trial of Probuphine at a poster session during The College on Problems of Drug Dependence 78th Annual Meeting in Palm Springs.
Probuphine is a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence.
The sensitivity analyses, commonly conducted following the primary analysis to test the robustness of the data, consistently support previous findings that participants who were clinically stable on sublingual buprenorphine at a dose of 8mg a day or less maintained stability when transferred to treatment with Probuphine.
The FDA in late May approved Probuphine for the long-term maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged stability on low-to-moderate doses of buprenorphine.
“These post hoc sensitivity analyses showed that even under the most conservative method, the Probuphine long-acting subdermal implant demonstrated efficacy in direct comparison with sublingual buprenorphine,” Dr. Richard Rosenthal, co-lead investigator and an author of the presentation, said in a statement.
According to Dr. Rosenthal, a Prof. of psychiatry and medical director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai, the analyses also supported previous findings that participants treated with the Probuphine implant were more likely to remain free of illicit opioids, compared with those on sublingual buprenorphine.
“These results hold great promise for Probuphine as a new option for clinicians and patients seeking greater access to medications for the maintenance treatment of opioid addiction,” he added.