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ASAM Submits Comments Regarding New Subcutaneous Injectable Buprenorphine Formulations

October 13, 2017

Indivior Letter

Braeburn Letter


ASAM submitted two comment letters to the Food and Drug Administration (FDA) regarding new subcutaneous injectable buprenorphine formulations. The FDA opened two dockets seeking comments on the new subcutaneous injectable buprenorphine formulations.


To date, the FDA has approved the sublingual tablet and sublingual film formulations of buprenorphine, and is in the process of reviewing the new injectable formulation. In the letters, ASAM reiterated support for new pharmacotherapies for addiction and that patients should have a robust and varied array of treatment options. Unlike the oral buprenorphine formulations, this once- or twice-monthly subcutaneous injection formulation has the potential to decrease the risk of diversion.


The letter also highlights that, as with all medications for opioid addiction, treatment with buprenorphine subcutaneous injection, should include evidence-based psychosocial interventions and ongoing monitoring for relapse, drug interactions and overdose risk.