Braeburn has been fighting the FDA over its award of Orphan Drug Designation to another opioid use disorder treatment that will prevent competition through November 2020. More than 2 million people in the U.S. have been diagnosed with the disease.
Braeburn is getting another shot on goal for potential approval of its opioid use disorder treatment, Brixadi. On Monday, a U.S. District Court Judge ordered the U.S. Food and Drug Administration to reconsider its final approval for the medication after the regulatory agency determined it could not approve it due to marketing exclusivity granted to Indivior’s opioid treatment.
Chief Judge Beryl A. Howell ordered the FDA to reconsider Braeburn’s application for approval “with deliberate speed,” the company announced late Monday. The legal proceedings started earlier this year after the FDA determined it could not approve Brixadi due to the marketing exclusivity held by another product, Indivior’s Sublocade. In the ruling, Howell said 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. Additionally, Howell noted in the ruling that the U.S. has been facing a national public health crisis regarding opioids and acknowledged the need for additional treatment options for patients with opioid use disorder.
Indivior’s Sublocade was approved in 2017 by the FDA. When it was approved, it was the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder. But, when Sublocade was approved, the FDA allowed Indivior to carry over its orphan drug status granted to a previous formulation of the treatment called Subutex. That provided the company with market exclusivity and blocked any competition through November 2020.
In December, the FDA granted Brixadi tentative approval after it met all regulatory standards for US approval, including safety, efficacy and quality. Brixadi is a weekly and monthly subcutaneous injection that can be administered without the need for prior dose adjustment on oral buprenorphine or a loading dose. That tentative approval did not sit well with Pennsylvania-based Braeburn. In response to that nearly two-year marketing delay, Braeburn filed a Citizen Petition with the regulatory agency calling on it to “protect the integrity and intent of the Orphan Drug Act by revoking the orphan drug designation for Sublocade.” The petition argues that opioid use disorder is not a bona fide orphan disease with over two million Americans diagnosed. Orphan drug status is typically granted to drugs that treat fewer than 200,000 patients. The Citizen Petition also called on the FDA to refuse to grant a seven-year orphan drug exclusivity period to Sublocade, which would likely prevent approval of any other OUD buprenorphine product until the end of 2024, the company said. At the same time, the company initiated court proceedings to overturn the marketing exclusivity provided to Indivior.
Mike Derkacz, president and chief executive officer of Braeburn said the company was pleased that the court decided in favor of Braeburn’s complaint. He said it is an “important step” toward bringing Brixadi to the public to treat opioid use disorder. Derkacz said Braeburn is looking forward to “working expeditiously with FDA to get Brixadi on the market as soon as possible.”
Indivior, which is currently the subject of a U.S. Department of Justice probe over its marketing of opioid use disorder treatments, has contested challenges to its market share. Last year, the company won an injunction against Dr. Reddy’s Laboratories from launching its generic version of Suboxone, an opioid addiction treatment. Indivior’s Suboxone One film was approved by the FDA in 2010. Dr. Reddy’s and its partner Mylan approved its generic version of Suboxone (buprenorphine and naloxone) sublingual film for opioid addiction.
