Braeburn Pharmaceuticals has surpassed the midway point for patient enrollment in its phase III study of Probuphine, which began in July. Probuphine is a buprenorphine subdermal implant being studied for the maintenance treatment of opioid dependence. Completion of the study is on track for the middle of 2015, with submission of the New Drug Application to the FDA expected to follow later in the year.
"We are encouraged by the speed with which stable opioid-dependent patients are enrolling in this trial," said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals. "We believe the pace of enrollment reflects the great need for new long-term maintenance treatment options for those suffering from opioid dependence. We will continue working with our clinical investigators to complete this study expeditiously, and if ultimately approved by the FDA, look forward to the opportunity to provide physicians and their patients a unique treatment alternative."
There are currently 21 clinical research sites with IRB approval to participate in the six-month, randomized, double-blind, double-dummy study. All sites are actively recruiting and screening patients. Ninety-five of 180 anticipated patients have been enrolled in the study. An additional 10 patients are awaiting scheduling for randomization, and 23 patients are in the middle of the screening process.
According to recent estimates, there are 2.2 million people with opioid dependence in the U.S. Approximately 20% of this population is addicted to illicit opioids, such as heroin, and the other 80% to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence had been sanctioned to a limited number of facilities in the U.S. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatments. As a result, an estimated 1.2 million people in the U.S. sought treatment for opioid dependence in 2011.