Titan Pharmaceuticals Inc. today released information regarding its phase 3 clinical study of Probuphine, an approved agent for opioid addiction. The company said it has completed 60 percent of its target patient enrollment and that it is nearly three months ahead of schedule for complete enrollment, initially set for the fourth quarter of this year.
The six-month, phase 3 study involves 250 patients throughout 21 sites in the United States, which will randomize Probuphine (100 patients), Suboxone® (100 patients) and placebo (50 patients).
This study is part of an overall strategy to obtain marketing approval of Probuphine for the treatment of opioid addiction throughout the United States and Europe.
Titan’s efforts are backed by the National Institutes of Health (NIH), which awarded the company a two-year $7.6 million Research and Research Infrastructure Grand Opportunities grant administered through the National Institute on Drug Abuse (NIDA). The grant covers roughly 50 percent of the cost of the phase 3 study; Titan will receive $5.6 million through September 2010.
Dr. Katherine L. Beebe, senior vice president of Clinical Development and Medical Affairs for Titan, and principal investigator of the study, said the support from the NIDA and NIH were integral to the company’s accelerated progress.
“We are extremely pleased with the rapid progress being made towards completion of this confirmatory safety and efficacy study,” Dr. Beebe stated in the press release. “Thanks to the support for Probuphine by NIDA/NIH and the hard work of our investigators and their staff we are able to quickly advance the Probuphine phase 3 clinical development program.”
According to the World Health Organization, about 2.8 million people in the United States and Europe are addicted to illicit opiates such as heroin; it is estimated that more than 2.0 million individuals in the U.S. alone are addicted to prescription opioid medications.
To Titan Executive Chairman Dr. Marc Rubin, the statistics of opioid addiction in comparison to the potential of Probuphine fuels the importance of the company’s studies.
“We are very encouraged with the progress of this important clinical study and believe that this is indicative of Probuphine’s potential to serve unmet needs in the opioid addiction community for treatment alternatives,” said Dr. Rubin.
The results of the study are slated for release in the second quarter of 2011.
For more information visit www.titanpharm.com
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