FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade

Regulatory NewsRegulatory News | 08 November 2019 |  By 

The US Food and Drug Administration (FDA) said Thursday that it has decided to revoke the orphan designation granted to Indivior’s opioid use disorder (OUD) treatment Sublocade (buprenorphine extended-release injection).

Approved as a sublingual tablet in 2002 and known as Subutex (buprenorphine), the drug received orphan designation and seven years of exclusivity thorough 2009. In 2017, FDA approved Indivior’s extended release injection of buprenorphine, known as Sublocade.

The company said in its FY 2018 report it’s targeting $1 billion-plus of peak annual net revenue from Sublocade, although it had net revenue of $12 million in FY 2018.

In December 2018, FDA tentatively approved Braeburn’s buprenorphine extended-release injection drug Brixadi, though the company is unable to market the drug until November 2020. If Sublocade receives orphan drug exclusivity as well, Braeburn said in its petition seeking to revoke the exclusivity that the company would be barred from marketing Brixadi until 2024.

Petition Granted

In revoking Sublocade’s orphan designation, FDA’s Lowell Schiller, principal associate commissioner for policy, explains in a letter to the Indivior competitor Braeburn’s lawyer that the Subutex orphan designation in 1993 should not have been granted initially because Indivior failed to establish that it would not recover the costs of developing its buprenorphine drug from the drug’s sales.

FDA also says it was not reasonable of Indivior to assume that the market size would remain constant for the first seven years of Sublocade’s marketing.

Schiller further explains how Indivior’s assertions and arguments for keeping the orphan designation do not change FDA’s conclusion. And the agency says that slight changes to Indivior’s initial assumptions, such as its assumption that 104,000 people would use buprenorphine or that the number of treatment facilities would not increase, would have resulted in the company making a profit off the drug.

FDA, which estimates the total prevalence of OUD to be between 1 million and 1.5 million, also explains how other initial assumptions were wrong and how Indivior failed to provide information about what other buprenorphine products could be developed.



© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy