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Pharmaceutical company questions FDA's decision to delay approval of anti-opioid drug

By John Suayan | Apr 16, 2019

WASHINGTON (Legal Newsline) – A Pennsylvania-based pharmaceutical company is suing the Food and Drug Administration, acting FDA Commissioner Norman E. Sharpless, the Department of Health and Human Services and HHS Secretary Alex M. Azar II for allegedly delaying the approval of a drug product it claims would combat the opioid crisis.

Braeburn Inc. filed the 32-page lawsuit April 9 in the U.S. District Court for the District of Columbia raising issue with the FDA’s decision not to approve its “new, long-lasting” injectable buprenorphine treatment, known as Brixadi, until Nov. 30, 2020.

The plaintiff developed Brixadi to fight the “national public health emergency” responsible for the deaths of nearly 50,000 people in the past year alone, and almost 400,000 people since 1999, according to the original petition.

Braeburn asserts that though the FDA has found the product “safe and effective following the completion of seven clinical studies,” the latter made the “arbitrary and capricious decision to give an unlawfully broad form of marketing exclusivity to another manufacturer’s product.”


“In particular, defendants have granted the other manufacturer’s product very broad exclusivity despite only providing it a narrow approval based on clinical trials conducted in a limited patient population,” court filings said. 

“Braeburn’s new treatment has been shown to help patients whom the other manufacturer’s product is not approved to treat and in whom it was never studied. Defendants’ impermissible interpretation of the exclusivity provisions of the Federal Food, Drug, and Cosmetic Act is thus depriving large numbers of OUD (opioid use disorder) patients of any access to potentially life-saving innovations for OUD treatment.”

While the application for Brixadi was pending before the FDA, the original petition said, a different buprenorphine product called Sublocade created by Indivior PLC was also considered.

“While both Brixadi and Sublocade are depot products, the formulation that each uses to control release of buprenorphine is entirely different. That difference leads to significant differences in when and how the drugs can be used, and – importantly – the patients to whom they can be administered,” the suit said.

Braeburn questions the approval of Sublocade on grounds Brixadi does not share important “conditions of approval” with its alleged rival drug product. The complainant touts Brixadi’s capability to treat “moderate to severe OUD without any requirement that patients undergo a seven-day initiation and dose-adjustment period with take-home oral buprenorphine.”

“Unlike Sublocade, Brixadi’s integrated system enables new-to-treat patients to receive an injection on their first visit to the doctor without first navigating seven precarious days on take-home oral buprenorphine, which is subject to the risks of abuse, misuse, and pediatric exposure,” the suit says.

An April 9 Yahoo! Finance article reported that Braeburn filed a citizen petition (CP) with the FDA “to protect the integrity and intent of the Orphan Drug Act by revoking the orphan drug designation for Sublocade injection for the treatment of opioid use disorder.”

The CP also calls 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, per the article.

Braeburn ultimately seeks a reversal of the FDA’s decision in addition to unspecified monetary damages.

The law firm Goodwin Procter LLP is representing the plaintiff.

U.S. District Court for the District of Columbia Case No. 1:19-CV-0982

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Goodwin Procter LLP U.S. District Court for the District of Columbia

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