FDA Revokes Orphan Drug Designation for Opioid Addiction Treatment

November 20, 2019

The FDA revoked Indivior’s orphan drug designation for its opioid addiction treatment Sublocade (buprenorphine extended-release injection) finding that it was improperly granted.

In response to a citizen petition from Braeburn — which received the agency’s tentative approval for its own buprenorphine extended release product, Brixadi, in December 2018 — the agency determined that it erroneously granted the orphan drug designation to Indivior because “it was unreasonable to conclude that there would be no cost recovery from sales of buprenorphine.”

In granting Braeburn’s petition, the agency determined that it was not reasonable to assume that the market size would remain constant for the first seven years of marketing Sublocade.

Lowell Schiller, the FDA’s principle associate commissioner for policy, wrote that the agency should not have assumed that the population of people seeking the treatment would stay the same, and that laws restricting opioid addiction treatment drugs at the time would not change.

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