The U.S. Food and Drug Administration (FDA) has approved a new monthly formulation of the drug buprenorphine for the treatment of opioid use disorder. The new product, known as Sublocade™, is a once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product for a minimum of seven days. Indivior is the first company to gain approval for a monthly injection of buprenorphine. Other buprenorphine formulations previously approved for the treatment of OUD include a tablet, film, or implant.
The FDA Commissioner, Scott Gottlieb, MD, made a statement addressing how the FDA plays a crucial role in the use of medications for opioid addiction treatment, first and foremost, through its role in the approval of new drugs. The FDA is taking steps to promote the development of new medications for the treatment of opioid use disorder, including new formulations of the existing drugs, like buprenorphine, that could allow for a more individualized treatment approach to better meet patient needs. The FDA is also taking steps to address current treatment gaps and promote a wider adoption of effective therapies, including ways to expand insurance coverage and assuring access to this life-saving treatment.
>> FDA Statement
>> Indivior Press Release
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