Brixadi Receives Tentative Approval to Treat Opioid Use Disorder
December 21, 2018 – The U.S. FDA has granted tentative approval to Brixadi™ (buprenorphine) extended release injection, manufactured by Braeburn Pharma, to treat moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product, or who are already being treated with buprenorphine.
OUD involves physical changes in the brain that drive the body’s physical dependence on opioids and affect an individual’s ability to function. The condition is characterized by opioid use that causes serious impairment or distress for the patient according to a set of defined criteria. Patients must meet at least two of these criteria to be diagnosed; those who meet four or more are considered to have moderate to severe OUD.
Buprenorphine, the active ingredient in Brixadi, was first approved to treat OUD in 2002. When prescribed and used appropriately, it can reduce the risk of relapse and help patients stay in treatment. It is available in multiple forms, including films, patches, sublingual tablets, and injection.
Using FluidCrystal® Injection Depot Technology, Brixadi delivers a slow, steady, continuous release of buprenorphine over a one-week or one-month period following injection. It must be administered by a qualified healthcare professional, and should be used as part of a comprehensive treatment program that includes counseling and psychosocial support. In a clinical study, Brixadi demonstrated superiority to daily treatment with sublingual buprenorphine/naloxone, the current standard of care. Patients involved in the study were using fentanyl, heroin, and/or injectable opioids at study initiation.
The FDA’s tentative approval of Brixadi confirms that the drug meets the necessary requirements for safety, efficacy, and quality. However, due to a period of exclusivity granted to Indivior’s Sublocade™ (buprenorphine extended release), Brixadi is currently ineligible for marketing in the United States. Sublocade received FDA approval in November 2017. The period of exclusivity ends in November 2020.