TTNP > Braeburn Pharmaceuticals Announces FDA Approves Probuphine(R) (buprenorphine) Implant: The First Implant for Treatment of Opioid Dependence DJNF
Patients and Providers Have a New Option to Combat Opioid Dependence
PRINCETON, N.J., May 26, 2016 /PRNewswire/ -- 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. "With 78 people in the U.S. dying each day from opioids, it's important that patients have more treatments to choose from as no one option will work for everyone. Probuphine is the first of what we hope will be many new and innovative approaches to treating this disease. We are grateful to all of the patients, investigators and to NIDA for their help and dedication that has brought us to this point. "
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."
The systemic side effects for Probuphine are similar to those that are seen with buprenorphine and in the Probuphine clinical trials included: headache, insomnia, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting. In addition, common implant site reactions included pain, itching, redness and swelling.
"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."
News 
Market Data 
Discover 
