FDA to re­voke or­phan des­ig­na­tion for opi­oid ad­dic­tion drug Sublo­cade

The 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, the 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, the 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

Low­ell Schiller FDA

In re­vok­ing Sublo­cade’s or­phan des­ig­na­tion, the 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.

The 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 the 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.

The 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.

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