PRINCETON, N.J. -- (BUSINESS WIRE) -- Braeburn Pharmaceuticals, today announced that former FDA Commissioner Frank E. Young, M.D., Ph.D., has joined the management team as Executive Vice President, Clinical and Regulatory Affairs. If approved, Braeburn’s first product will be Probuphine®, a buprenorphine implant for the maintenance treatment of opioid addiction, currently under review at the U.S. Food and Drug Administration (FDA). Braeburn has licensed rights from Titan Pharmaceuticals, Inc. to commercialize Probuphine in the U.S. and Canada.
“I joined Braeburn Pharmaceuticals because helping people overcome the life-threatening risks and health hazards of opioid addiction while supporting their journey to recovery is among the highest priorities of public health today. I am impressed with Braeburn’s commitment to develop therapies to mitigate health problems associated with opioid addiction,” said Dr. Young. “I look forward to working with FDA and the Braeburn team to satisfy fully FDA’s concerns.”
“Dr. Young brings extensive knowledge and experience to the Braeburn team at this important time for our company,” said Behshad Sheldon, President and Chief Operating Officer of Braeburn Pharmaceuticals. “As we continue to work collaboratively with FDA, we are confident that Dr. Young’s counsel will help us navigate the process and expedite the evaluation of Probuphine to make this novel treatment option available to patients suffering from opioid addiction.”
Dr. Young served as Commissioner of the U.S. Food and Drug Administration from 1984 to 1989 during the Reagan and Bush administrations. Subsequently, he served as Deputy Assistant Secretary in the George H.W. Bush administration, and Director of both the Office of Emergency Preparedness and the National Disaster Medical System during the Clinton Administration. Prior to entering government, Dr. Young served as Chairman of the Department of Microbiology and Professor of Microbiology, Pathology, Radiation Biology and Biophysics at the University of Rochester, New York, as well as Dean of the School of Medicine and Dentistry, Director of the Medical Center and Vice President for Health Affairs at the University of Rochester. Dr. Young has contributed to more than 200 scientific articles in the fields of biotechnology and microbiology, including development of some of the earliest cloning enzymes, vectors and vehicles. More recently, Dr. Young served as Interim Vice President for Clinical and Regulatory Affairs at Bioventus LLC. He was co-founder and CEO of the Cosmos Alliance. Dr. Young also served as a partner of Essex Woodlands from 2006-2013 and continues as Adjunct Partner.
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 confirmatory study of 287 patients (published in the journal Addiction).
In October 2012, FDA granted Probuphine priority review designation, based upon its potential for improved compliance and diversion resistance. In March 2013, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted ten in favor, four against to approve Probuphine. In April 2013, the FDA issued a Complete Response Letter (CRL) and on September 4, 2013, a meeting request was submitted to the FDA to discuss the response to the CRL for Probuphine.
Braeburn Pharmaceuticals, an Apple Tree Partners company, develops and commercializes innovative medical products and is 100 percent dedicated to the field of addiction. If FDA approves the new drug application (NDA), the company’s first product will be Probuphine®, a buprenorphine implant currently under FDA priority review for the maintenance treatment of opioid dependence. Braeburn’s executive team has decades of experience successfully bringing medically significant pharmaceuticals and medical devices to market, as well as a deep understanding of clinical development and quality assurance processes.