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ASAM Applauds FDA's Approval of New Monthly Injectable Buprenorphine Formulation

December 6, 2017

On December 30, 2017, the Food and Drug Administration (FDA) announced the approval of Sublocade, a monthly formulation of buprenorphine subcutaneous injection for treatment of opioid dependence. This injection is the first monthly formulation of buprenorphine to be approved by the FDA.


Buprenorphine has been shown to be safe and effective for the treatment of opioid dependence. The approval of this new buprenorphine formulation will expand treatment options for patients. The American Society of Addiction Medicine applauds the efforts of the FDA and manufacturers to expand treatment options for people with addiction and to minimize the risks of diversion, accidental exposure and/or overdose.


“The American Society of Addiction Medicine supports the development and manufacturing of medications that aid in the treatment of addiction,” said Dr. Kelly Clark, President, American Society of Addiction Medicine. “The introduction of novel pharmacotherapies supports this goal. Addiction patients, like all patients, should have available to them a robust and varied array of treatment options, as no one treatment modality is appropriate or therapeutic for everyone.”