Braeburn Pharmaceuticals announced today the initiation of a new clinical trial for Probuphine® based on clear guidance from the U.S. Food and Drug Administration (FDA). The study, which was submitted for FDA review in mid-March, is expected to begin enrollment by mid-year and to be completed by the middle of 2015.
"The responsiveness and insightful guidance from the FDA have been helpful in solidifying our decision to move forward with building Braeburn's strong focus in addiction medicine," said Behshad Sheldon, President and Chief Executive Officer of Braeburn Pharmaceuticals. "We are keen to begin the new trial for Probuphine, which if approved should lay a strong foundation for our company."
The clinical study is a randomized, double blind, double dummy design that is expected to enroll approximately 180 patients into two parallel treatment arms. The study population will be clinically stable patients who are receiving maintenance treatment with an approved sublingual formulation containing buprenorphine at a daily dose of 8mg or less. Patients will be randomized either to receive four Probuphine implants or to continue daily sublingual buprenorphine therapy. In keeping with the double blind design, those receiving Probuphine implants will also take daily placebo sublingual pills, and those randomized to sublingual buprenorphine pills will receive four placebo implants. All patients are expected to be treated for six months, and the primary analysis will be a non-inferiority comparison of responders in the two arms.
The Braeburn team has already revised the final study protocol to incorporate the FDA's guidance. Preparations are also under way to qualify investigator sites, obtain Institutional Review Board (IRB) approvals and train the clinicians in study procedures.
"As the number of people living with opioid dependence in this country continues to rapidly increase, the development of medications like Probuphine is critical to addressing the need for new and effective treatment options," said Frank E. Young, M.D., Ph.D., Executive Vice President, Clinical and Regulatory Affairs, Braeburn Pharmaceuticals. "Braeburn strongly believes in the potential for Probuphine to offer people living with opioid dependence a unique approach to achieving sustained, long-term recovery. We remain committed to working with the FDA and our partner Titan Pharmaceuticals toward the goal of adding Probuphine to the short list of proven medication-assisted treatment (MAT) options."