More than four years after receiving tentative approval for its opioid use disorder treatment, Braeburn Inc. has received Food and Drug Administration marketing clearance for Brixadi.

Brixadi was approved by the FDA as an extended-release, injectable medication available in weekly and monthly doses.

Mike Derkacz, president and CEO of Plymouth Meeting-based Braeburn, called the approval a "significant step forward" in the fight 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 in a statement. "Additional medication options for opioid use disorder will support health care providers in addressing the needs of their patients with opioid use disorder." 

Brixadi received marketing clearance for use as a treatment for moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product. 

More than four years ago, in December 2018, the FDA granted conditional approval to Braeburn for Brixadi, stipulating the product could not be marketed for three years because Indivior, a pharmaceutical company with offices in the United Kingdom and Virginia, was previously granted orphan drug designation for a competing product, called Sublocade, that gave it market exclusivity.

Braeburn filed a citizens petition in April 2019 with the FDA, asking for the federal government to revoke Indivior's orphan designation for Sublocade, arguing opioid use disorder is not a bona fide orphan disease. Such a designation is indicative of conditions affecting 200,000 or fewer people.

The FDA granted Braeburn's citizens petition in November 2019.

Braeburn then had to resubmit its new drug application for Brixadi in 2021, after the FDA failed to provide final approval of the new drug candidate in December 2020 because of deficiencies found during an inspection at a third-party manufacturing facility. Braeburn responded to additional questions from the FDA about the application last year, which led to Tuesday's approval.

Braeburn said it expects to launch Brixadi through a restricted distribution program in September.

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John George

Senior Reporter

Philadelphia Business Journal