Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.
“Patients and their doctors now have Probuphine as a new option for the six-month treatment of opioid dependence. Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases—with evidence-based medicine,” said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals.
Buprenorphine is a commonly prescribed medication for the treatment of opioid dependence. Until today, it has only been available in sublingual (oral) formulations. Probuphine received a priority review based on the potential to reduce accidental pediatric exposure.
“Probuphine is the first treatment for opioid dependence that provides long-term delivery of an evidence-based medicine,” said Richard Rosenthal, Professor of Psychiatry, Icahn School of Medicine at Mount Sinai, Medical Director of Addiction Psychiatry, Mount Sinai Behavioral Health System. “Probuphine offers clinically stable patients a new way to continue taking medicine, ensuring the dose prescribed is the dose taken.”
“Probuphine represents a significant step forward in addressing the serious lack of new treatment options in the last 15 years. With strong support from the President and the Secretary of Health and Human Services this year to expand access to medication assisted treatment, addiction specialists like myself are more confident we will be able to get more patients the treatment they desperately need,” said Kelly J. Clark, MD, MBA, DFASAM, DFAPA, President Elect, American Society of Addiction Medicine, Chief Medical Officer, CleanSlate Centers. “Opioid dependence touches people from all walks of life, no matter their socioeconomic status, race or gender; the more we educate and innovate the better chance we have at reducing the prevalence of this terrible disease.”
“Buprenorphine is an effective treatment for opioid dependence but was previously only available in pill or film formulation which can be lost, forgotten or stolen,” said Frank J. Vocci, Ph.D., president and senior research scientist, Friends Research Institute. “Probuphine’s inherent value as an implant is that patients receive constant levels of buprenorphine for up to six months without having to administer treatment on a daily basis. This is an unprecedented benefit of a treatment for opioid dependence.”
.png)
