Philadelphia Business Journal, April 9, 2019

Philadelphia Business Journal, April 9, 2019

Battle brewing over opioid abuse disorder drugs

By John George

Braeburn Inc. filed a Citizen Petition with the Food and Drug Administration Tuesday asking the federal agency to revoke its orphan drug designation granted to a competitor’s drug approved to treat opioid use disorder (OUD).


Plymouth Meeting-based Braeburn, whose own experimental OUD drug called Brixadi is currently stuck in regulatory limbo also is asking FDA not to grant a seven-year orphan drug exclusivity period to Indiivior, which markets the competing OUD drug Sublocade.


“At a time of national emergency, the FDA should follow through on its commitment to expand access to new addiction treatments,” said Mike Derkacz, president and CEO of Braeburn.”It is universally accepted that OUD patients need more treatment alternatives and more access.”


In December, the FDA granted tentative approval to Brixadi, Braeburn’s extended-release injectable OUD drug containing buprenorphine. Buprenorphine is also the active ingredient in Indivior’s Sublocade product.


The FDA said Brixadi was not eligible for full approval until Nov. 30, 2020, due to FDA awarding a three-year “clinical exclusivity” period to Sublocade.


That exclusivity period is separate from the exclusivity period referenced in Braeburn’s petition filed Tuesday. Braeburn said it also intends to go to court in a separate action to overturn FDA’s three-year clinical exclusivity decision for Sublocade, which would pave the way for the immediate approval of Brixadi.


Representatives of Indivior, which has offices in Berkshire, England, and Richmond, Va., were not immediately available for comment.


In its petition, Braeburn argues allowing the Sublocade designation — and the pending seven-year exclusivity period — violates the intent of the Orphan Drug Act because it would mean no new product with buprenorphine would be able to enter the market until late 2014.


The company’s main argument is orphan drug designation and the accompanying exclusive marketing period are intended to treat “rare conditions with small, underserved patient populations,” not conditions such as OUD, which affects more than 2 million Americans.


The petition notes in the 35 years since the Orphan Drug Act passed, the designation was awarded if three instances when there were more than 200,000 Americans affected by a condition, but companies argued there was “no reasonable expectation” for it to recover development and marketing costs.


Subutex, an earlier Indivior UAD drug, received an Orphan Drug Designation under that exception, according to the Braeburn petition, and the ‘grandfathered’ the Subutex’s designation to Sublocade without a review of the data because both product have the same developer.


Braeburn argues “extraordinary changes” occurred in the opioid abuse disorder following the enactment of the Drug Addiction Treatment Act in 2000. The act, the company said, resulted in an enormous expansion of the use of Subutex, resulting in hundreds of millions of dollars of sales.


“The FDA has the legal authority, but more importantly a clear obligation to its public health mission, to revoke the Orphan Drug Designation,” Derkacz said. “With millions impacted by the opioid crisis, Opioid use disorder is clearly not an orphan disease and Sublocade is not a bona fide orphan drug.”

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