Court order gives Braeburn new hope for its opioid-abuse disorder drug

By John George  – Senior Reporter, Philadelphia Business Journal Jul 30, 2019, 12:37pm EDT

A Montgomery County pharmaceutical company’s effort to gets its opioid abuse treatment drug into the market has received a boost from the courts.

Last week, the U.S. District Court for the District of Columbia granted Plymouth Meeting-based Braeburn Inc.’s motion for summary judgment, which vacates a December 2018 decision by the Food and Drug Administration to award a three-year market exclusivity period to Sublocade, an opioid abuse disorder drug marketed by Indivior.

The market exclusivity blocked Brauburn from getting final approval for its opioid abuse disorder treatment Brixadi, which received tentative approval from the FDA, from getting final approval until November 2020.

The court remanded Braeburn’s application for final approval of Brixadi back to FDA for reconsideration “with deliberate speed.”

Chief Judge Beryl A. Howell noted that the FDA determined Sublocade’s exclusivity in the broadest sense, and failed to demonstrate how Sublocade’s exclusivity was consistent with FDA’s previous decisions. Howell also noted the need for additional treatment options for patients with opioid use disorder.

“We are pleased by the District Court’s decision, which is an important step toward making Brixadi available to health care providers and patients,” said Mike Derkacz, President and CEO of Braeburn. “We look forward to working expeditiously with FDA to get Brixadi on the market as soon as possible.”

In a separate but related matter, Braeburn is continuing to wait for a decision from FDA regarding the Citizen Petition the company filed with the agency requesting that FDA refuse to grant orphan drug exclusivity to Sublocade on the basis that opioid use disorder is not a bona fide orphan disease. Orphan diseases are those that afflict fewer than 200,000 people, while more than two million Americans have been diagnosed with opioid use disorder. The added market exclusivity is awarded by the FDA in some instances in order to incentivize companies to pursue drugs for small patient populations.

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