Braeburn Pharmaceuticals' Probuphine® Study Hits Enrollment Milestone

95 of 180 Patients Enrolled; Additional Patients Screened, Awaiting Randomization

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Sep 24, 2014, 08:00 ET

PRINCETON, N.J., Sept. 24, 2014 /PRNewswire/ -- Braeburn Pharmaceuticals today announced that it has surpassed the midway point for patient enrollment in its Phase 3 study of Probuphine^®, which began in July of 2014. 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 (NDA) to the U. S. Food and Drug Administration (FDA) expected to follow later in the year.

Braeburn Pharmaceuticals (PRNewsFoto/Braeburn Pharmaceuticals)

"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. As of today 95 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. More information on primary endpoints as well as inclusion and exclusion criteria for the study can be found here.

"It is fitting for Braeburn to share progress on patient participation in its Probuphine study during National Recovery Month, a time when the addiction community is encouraged to spread the positive message that treatment is effective and people can and do recover," said Frank Young, M.D., Ph.D., executive vice president, Clinical and Regulatory Affairs. "It is our hope that, one day, Probuphine will be an approved long-term maintenance treatment option to assist the overwhelming number of people with opioid dependence struggling to get their lives back."

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.

About Probuphine
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 $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 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.

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SOURCE Braeburn Pharmaceuticals