FDA in Brief: FDA finalizes new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder

FDA in Brief: FDA finalizes new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder

Today, the U.S. Food and Drug Administration issued a final guidance, “Opioid Use Disorder: Developing Buprenorphine Depot Products for Treatment,” which outlines the FDA’s current thinking about drug development and trial design issues relevant to the study of buprenorphine depot products, such as modified-release products for injection or implantation. The guidance includes minor changes to the draft document published in April 2018. Improving access to prevention, treatment, and recovery services, including the full range of medication-assisted treatment (MAT), is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of HHS’ Five-Point Strategy to Combat the Opioid Crisis. There are currently three FDA-approved drugs for MAT – methadone, buprenorphine, and naltrexone – that have been demonstrated to be safe and effective in combination with counseling and psychosocial support to treat opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to ...