FDA revokes orphan status for Indivior's opioid addiction treatment drug

In an unusual twist, the FDA revoked orphan status for Sublocade, an opioid addiction treatment manufactured by Indivior that was approved two years ago, according to STAT

The move allows competitors to bring their own injectable buprenorphine treatments to market. 

Sublocade was granted orphan status because an earlier version of the drug, Subutex, received orphan status when it was approved in 1994.

When it obtained orphan status for its first version of the drug, Indivior used a provision in the Orphan Drug Act that allows the FDA to grant orphan status when a drugmaker can show its drug is unlikely to be profitable and the company will not be able to recover its development costs.  

Though Indivior stopped marketing Subutex in 2011, the FDA automatically gave Sublocade orphan status because it contains the same active ingredient as Subutex. The orphan status gave Sublocade seven years of market exclusivity, meaning it wouldn't have any competition until 2024. 

Critics and competitors argued Indivior did not deserve to receive orphan status for Sublocade because it made billions of dollars from Subutex. Competitor Braeburn Pharmaceuticals filed a citizens' petition in April 2019 asking the FDA to revoke the drug's orphan status. 

The FDA responded Nov. 7 and said it shouldn't have given Sublocade orphan status. 

After a reevaluation the FDA said it "erroneously granted" orphan status to Sublocade and argued it was "unreasonable to conclude that there would be no cost recovery" from Sublocade sales in the U.S., the FDA wrote

As a result, Braeburn said it plans to seek FDA approval to market its opioid addiction drug, Brixadi, and hopes to make it available by the end of 2020. 

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