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PRINCETON, N.J., July 21, 2014 /PRNewswire/ -- Braeburn Pharmaceuticals today announced that the first patients have been enrolled in its Phase 3 clinical study of Probuphine®, a subdermal implant for the maintenance treatment of opioid dependence. The trial is designed to address questions the agency posed in its complete response letter last year, after its review of the original New Drug Application (NDA). Completion of the Braeburn Phase 3 study is expected by the middle of 2015, to be followed by resubmission of the NDA later in the year.
"With an estimated 2.2 million Americans suffering from opioid dependence, there is an acute need for innovative and effective treatment options," said Behshad Sheldon, President and CEO of Braeburn Pharmaceuticals. "We believe the fast pace with which a number of sites received IRB approval following our recent investigator training indicates the addiction community's support and need for novel treatments like Probuphine. Braeburn is committed to continue working with our clinical investigators to identify appropriate study patients and expedite enrollment in our Probuphine study."
Braeburn held investigator training sessions in June to review clinical study procedures, including training for implant insertion and removal. To date, fifteen sites have obtained IRB approvals, and Braeburn expects an additional six sites to be operational within the next few weeks. Fourteen sites are actively screening patients for randomization into the study, and five patients have already been enrolled.
"For the vast majority of people with opioid dependence, medication-assisted therapy (MAT) is a critical component to achieve and sustain recovery; however, current options have limitations that may hinder compliance," said Richard Rosenthal, M.D., Professor of Psychiatry, Icahn School of Medicine at Mount Sinai, Medical Director of Addiction Psychiatry at Mount Sinai Behavior Health System and Co-Lead Investigator of Braeburn's Phase 3 Probuphine clinical study. "Given the escalating scope and gravity of the opioid addiction epidemic, there is no question more tools are needed to better arm patients against their life-threatening disease."
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 consists of clinically stable patients who are receiving maintenance treatment with an FDA-approved sublingual formulation containing buprenorphine at a daily dose of 8 mg or less. Patients are being randomized to receive either four Probuphine implants, or to continue daily sublingual buprenorphine therapy. To enable the double-blind design, those receiving Probuphine implants are required to take daily placebo sublingual pills, while those continuing on their stable dose of sublingual buprenorphine pills are required to be treated with four placebo implants. The 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.
"This study is of particular interest to the addiction community because it focuses on people who have been stable on a relatively low dose of buprenorphine, a growing segment of the opioid dependent population that has seldom been the focus of clinical research," said Frank Vocci, Ph.D., President, Friends Research Institute, Inc. and Co-Lead Investigator of Braeburn's Phase 3 Probuphine clinical study. "Providing stable patients with a long-acting treatment like Probuphine will ideally help them stay on track with their recovery, making Probuphine a natural next step treatment option for long-term recovery."
About Opioid Dependence
According to recent estimates, there are 2.2 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 daily dosed sublingual tablets and films, with reported 2012 sales of $1.5 billion in the United States.
Probuphine was developed by Titan Pharmaceuticals, Inc. using its ProNeura continuous drug delivery system, which 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 in 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).
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is focused on developing and commercializing new treatment options for serious neuropsychiatric disorders, including addiction, in order to help those whose suffering is compounded by the stigma associated with their disease, and for whom long-acting medicines are particularly beneficial. In December 2012 Braeburn licensed the U.S. and Canadian development and commercialization rights for its first product, Probuphine®, a buprenorphine subdermal implant for the maintenance treatment of opioid dependence. Probuphine is currently the subject of a Phase 3 clinical study designed to address questions the FDA posed in its complete response letter last year, after review of the original NDA. Completion of the study is expected by the middle of 2015, to be followed by resubmission of the NDA later in the year.
Braeburn's executive team has decades of experience successfully bringing medically significant pharmaceutical brands to market in several therapeutic areas including psychiatry, cardiovascular, metabolics, oncology, and dermatology. To learn more, please visit www.braeburnpharma.com.
Sherry Feldberg/Helen Shik
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SOURCE Braeburn Pharmaceuticals