Braeburn Pharmaceuticals, Princeton, NJ, announces 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.”
According to recent estimates, there are approximately 2.7 million people with opioid dependence in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent 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.
Probuphine is an investigational subdermal implant designed to deliver continuous, around-the-clock blood levels of buprenorphine for six months following a single treatment, and to simplify patient compliance and retention. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablets and film formulations, with reported 2012 sales of approximately $1.5 billion in the United States. Probuphine was developed using ProNeura™, Titan’s continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in a simple office procedure, and removed in a similar manner at the end of the treatment period. The drug substance is released slowly and continuously through the process of dissolution resulting at a steady rate of release.
The efficacy and safety of Probuphine has been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)) and a follow-on study of 287 patients (published in the journal Addiction).Related Articles: