FDA Announces New Actions to Encourage Medication-Assisted Therapy for Opioid Abuse | Practical Law

FDA Announces New Actions to Encourage Medication-Assisted Therapy for Opioid Abuse | Practical Law

FDA Commissioner Scott Gottlieb, M.D., announced new actions on opioid abuse focusing on patient access to medication-assisted therapy.

FDA Announces New Actions to Encourage Medication-Assisted Therapy for Opioid Abuse

Practical Law Legal Update w-011-9213 (Approx. 2 pages)

FDA Announces New Actions to Encourage Medication-Assisted Therapy for Opioid Abuse

by Practical Law Life Sciences
FDA Commissioner Scott Gottlieb, M.D., announced new actions on opioid abuse focusing on patient access to medication-assisted therapy.
On November 30, 2017, FDA Commissioner Scott Gottlieb, M.D., announced FDA actions on opioid abuse focusing on patient access to medication-assisted therapy (MAT). MAT for opioid addiction uses drugs to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve physiological cravings, and normalize body functions.
The FDA has approved formulations of buprenorphine, methadone, and naltrexone for opioid MAT. This includes the recent approval of Indivior, Inc.'s Sublocade™, the first once-monthly injectable depot buprenorphine extended-release product. An injectable depot formulation forms a deposit and releases its active compound over a certain period.
The FDA is planning two new guidances to encourage the development of new MAT drugs. The first guidance will describe the FDA's guidelines for the approval of depot formulations of buprenorphine for opioid dependence. The second guidance will describe how to establish additional endpoints for depot buprenorphine drug studies.
Additionally, the FDA plans to promote wider adoption of MAT by:
  • Convening experts and other parties to discuss the benefits of MAT, including studies that show community-wide reductions in overdoses following the expansion of MAT.
  • Revising buprenorphine, methadone, and naltrexone product labeling to explain that patients may need longer treatment (perhaps a lifetime) to have a sustained recovery.
  • Reducing the stigma associated with the use of MAT products.
Sources: FDA: Statement from FDA Commissioner Scott Gottlieb, M.D., on the Approval of a New Formulation of Buprenorphine and FDA’s Efforts to Promote More Widespread Innovation and Access to Opioid Addiction Treatments, November 30, 2017 and FDA Approves First Once-Monthly Buprenorphine Injection, a Medication-Assisted Treatment Option for Opioid Use Disorder, November 30, 2017.