Titan Pharmaceuticals, Inc. announced on August 13 that data from its previously completed and announced Phase 3 placebo- and active drug-controlled confirmatory clinical study of Probuphine®, evaluating the safety and efficacy of its subdermal implant for the maintenance treatment of opioid dependence in adult patients, were published online in the journal Addiction. The paper is expected to appear in a future print issue of the journal.
Probuphine is an investigational subdermal implant designed to deliver continuous and persistent, around the clock blood levels of buprenorphine for six months following a single treatment, and to simplify patient compliance and retention.
Key Probuphine findings outlined in the publication include:
- Probuphine results were statistically significant for the trial’s protocol defined primary endpoint based on the percentages of urine samples that were negative for illicit opioid use, and incorporating patient self-reported opioid use over the 24-week treatment period (p
- Patients receiving the Probuphine implant had a higher study completion rate relative to placebo (64 percent vs. 26 percent (p
- Patients receiving the Probuphine implant had lower clinician-rated (p
- Patients in the Probuphine arm and the SUBOXONE® arms had similar results for the mean number of urines that tested negative for illicit opioids (Probuphine: 36 percent SUBOXONE: 35 percent)
This study of 287 patients was funded by a grant from the National Institute on Drug Abuse (NIDA) and by Titan Pharmaceuticals.
Source: Yahoo.com – August 13, 2013