FDA, Legal

Braeburn petitions FDA to revoke Sublocade orphan designation

A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the FDA to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).

“Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the petition states.

In December, the FDA tentatively approved Braeburn’s own buprenorphine extended-release injection drug Brixadi, though the company is unable to market the drug during Sublocade’s three-year exclusivity period which expires in November 2020. If Sublocade receives orphan drug exclusivity as well, Braeburn would be barred from marketing Brixadi until 2024.

In the petition, Goodwin argues not only that Sublocade should not be eligible for orphan designation, but that an earlier version of the drug, Subutex (buprenorphine sublingual tablet), should not have qualified for orphan designation in the first place.

Subutex was granted orphan designation in 1994 based on a rarely used pathway that allows drugmakers to receive orphan designation for products that would not qualify for the designation based on the intended patient population when there is “no reasonable expectation” that the costs of developing the drug will be recovered from US sales.

The petition also makes the claim that the cost recovery analysis used to justify the orphan designation was “inaccurate and misleading” as Subutex brought in more than $285 million in sales since its approval in 2002.

According to a 2009 FDA Law Blog article, only three approved drugs had been granted orphan designation based on a cost-recovery argument and a 2018 report from the Government Accountability Office says that “designations under these circumstances [are] rare” due to the fact that sponsors must provide an estimate of their expected costs and revenues for the first seven years the drug is on the market.

Additionally, the petition takes issue with the method used by the FDA to apply the orphan designation granted to Subutex to Sublocade without Indivior needing to submit a new request for the designation or provide a plausible hypothesis that the drug is clinically superior to Subutex.

“This informal policy allows Sublocade to ‘piggy-back’ on the [orphan drug designation] granted to another drug,” the petition states, noting that this policy of transferring orphan designation “is not set forth or explained in any FDA regulation or guidance document.”

Because Sublocade is expected to reach blockbuster status and the potential patient population for the drug is in the millions, Goodwin argues that Sublocade would never qualify for orphan designation on its own merits.

The petition also calls on the FDA to refuse to grant, or to revoke if granted, a seven-year period of orphan exclusivity for Sublocade, as Indivior already received orphan exclusivity for Subutex when it was approved in 2002.


First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.


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Recursion Pharmaceuticals Salt Lake City, UT
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