PRINCETON, N.J. and BALTIMORE, April 15, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals announces presentation of data from the Phase 3 study of Probuphine, a six month subdermal buprenorphine implant for the long-term maintenance treatment of opioid addiction, today at the 47th Annual American Society of Addiction Medicine (ASAM) Conference. ASAM is a professional society representing over 3,700 physicians, clinicians and associated professionals in the field of addiction medicine. The study demonstrated that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine. Today's presentation of these findings is the first at a scientific medical meeting. The FDA is expected to make a decision on the approval of Probuphine by May 27, 2016.
"This was the first head to head comparison study of Probuphine and sublingual buprenorphine, demonstrating the efficacy of a long acting six month buprenorphine implant," said co-lead investigator and author of the study Richard N. Rosenthal, M.D., Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. "The study results show that participants in the implant group sustained clinical stability over the course of six months. The implant group was also more likely to remain free from illicit opioids at 85.7 % compared to 71.9 % of those maintained on sublingual buprenorphine. If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option."
The double-blind, double-dummy study was designed to determine the efficacy and safety of Probuphine as a maintenance treatment. The primary endpoint of non-inferiority was met—the responder rate was 87.6 percent in the sublingual buprenorphine group and 96.4 percent in the Probuphine group. The results showed statistically significant superiority for the implant versus the oral formulation (p=0.034). Side effects from treatment with buprenorphine included constipation, gastroenteritis, nasopharyngitis, headache and depression. Implant site related side effects included pain, pruritus, bruising and erythema.
"Like any chronic disease, the ability to personalize treatment is key to long-term success and quality of life for opioid dependent individuals," said Frank J. Vocci, Ph.D., president and senior research scientist, Friends Research Institute. "The data presented today on Probuphine provides hope for a new option that could address critical issues like medication compliance and the risks of oral buprenorphine."
"We are proud to be presenting the results of our pivotal trial at this prestigious gathering of addiction specialists. We are indebted to the investigators and patients suffering from opioid addiction who participated in this study," said Behshad Sheldon, president and CEO, Braeburn Pharmaceuticals. "We hope for a speedy conclusion to the FDA's review of these data and to bring a potentially valuable new medicine to patients."
About Opioid Dependence and Buprenorphine
Opioid dependence is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.4 million people struggle with opioid dependence and, according to the Centers for Disease Control, 78 people die each day from the disease. Despite the growing body of evidence that opioid addiction is not a choice or a moral failing, individuals struggling with this disease continue to be stigmatized. Research has shown that opioid dependence is a pre-disposed genetic condition that is best treated with a combination of medication and counseling. Usually, opioid dependent individuals cannot sustain recovery without long-term medical assistance that includes opiate replacement therapy, such as buprenorphine.
Buprenorphine is an opioid antagonist, which allows individuals to stop opioid use without experiencing withdrawal symptoms. Buprenorphine is currently only available in oral form and must be taken daily. While highly effective, self-administration of buprenorphine can lead to issues related to compliance, misuse, abuse, and even pediatric exposure and overdose. Buprenorphine is the third most seized drug according to the U.S. Drug Enforcement Agency.
Probuphine is currently undergoing final review by the U.S. Food and Drug Administration (FDA) following a 12 to 5 vote in January by the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) in favor of approving Probuphine. If approved, Probuphine would be the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction. The implant was developed using Titan Pharmaceuticals' proprietary platform technology, ProNeura™, a non-biodegradable drug delivery implant designed to provide continuous, long- term steady state levels of medication in the blood. It is administered in a short subdermal insertion procedure in a physician's office and removed similarly at the end of the treatment period.
For more information about Probuphine, please visit www.braeburnpharmaceuticals.com.
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions, which are often complicated by stigma and present significant public health challenges. Braeburn's investigational product pipeline consists of long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Candidates include: Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.
Sherry Feldberg or Rachel Gross
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SOURCE Braeburn Pharmaceuticals