On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.
According to the FDA press release, the buprenorphine implant that is inserted in the upper arm provides “a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.” Previously, only a buprenorphine pill or film that dissolves under the tongue have been available. Physicians will be required to undergo special training to insert and remove the implant.
Last March, HHS announced its targeted initiative aimed at reducing prescription opioid and heroin-related overdose, death and dependence. HHS enumerated three priority areas: (i) providing training and educational resources, such as updated prescriber guidelines, (ii) increasing the use of naloxone (an antidote that treats a narcotic overdose), and (iii) expanding the use of Medication-Assisted Treatment (MAT) that combines the use of medication – including methadone, buprenorphine, or naltrexone – and behavioral therapies to treat substance use disorders.
FDA’s approval of Probuphine expands the MAT options available for opioid addiction care. As stated in the FDA release, and according to the Substance Abuse and Mental Health Services Administration, “patients receiving MAT for their opioid use disorder cut their risk of death from all causes in half.”