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.

Im­age: An­drew Harnik AP

Fangliang Zhang, AP Images

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