After Four Long Years, Plymouth Meeting-Based Braeburn Receives FDA Clearance for Opioid Use Disorder Drug

Brixadi Braeburn.
Image via Braeburn.

Braeburn, which is based in Plymouth Meeting, has received Food and Drug Administration marketing clearance for its opioid use disorder drug Brixadi four years after being given tentative approval, writes John George for the Philadelphia Business Journal.

Brixadi was approved as an extended-release, injection medication that can be administered in either weekly or monthly doses. The drug can be used as a treatment for moderate to severe opioid use disorder in patients who have begun treatment or have been previously treated with transmucosal buprenorphine.

Mike Derkacz, president and CEO of Braeburn, said that this approval is an important step forward in the battle against opioid use disorder.

“Over the last three years the United States experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially people with opioid use disorder and people in recovery,” Derkacz said.

“Additional medication options for opioid use disorder will support health care providers in addressing the needs of their patients with opioid use disorder.”

Braeburn plans on beginning to distribute Brixadi in September in a limited release.

Read more about Braeburn in the Philadelphia Business Journal.


Learn more about Brixadi.

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