Titan Pharma's opioid addiction implant shows promise in phase III
- Titan Pharmaceuticals/Braeburn Pharmaceuticals announced results on Monday from a phase III trial of Probuphine, a small, subdermal rod-like implant that is embedded into the arm and releases buprenorphine HCl, for treatment of opioid addiction, over the course of six months.
- The study's primary endpoint was non-inferiority compared to oral buprenorphine tablets—a goal that Probuphine achieved.
- Probuphine was rejected once by the FDA in 2013. But Titan/Braeburn plans to resubmit for approval later this year, and the results of these trials will form the basis of that filing.
In the late-stage trial, 96.4% of opioid-addicted patients responded to Probuphine versus 87.6% who responded to the oral medication.
More strikingly, there was a statistically significant difference between the number of participants who passed monthly urine tests checking for the presence of opiates between the two groups. About 72% of the oral medication patients passed all six of the six monthly urine tests, while 88% of Probuphine users passed all six tests.
"This study provided the best opportunity to assess the safety and effectiveness of maintenance treatment with Probuphine based on a comparison with the current standard of care. We are extremely pleased with these strong results, which we believe underscore the important clinical benefits that Probuphine may be able to provide," said Kate Glassman Beebe, PhD, Titan's executive vice president and chief development officer, in a statement.
"We look forward to resubmitting the NDA later this year and to potentially securing approval for the product in the first half of 2016."