FDA ap­proves first non-opi­oid to treat with­draw­al symp­toms in adults

The opi­oid ad­dic­tion mar­ket got a new play­er Wednes­day with the FDA ap­proval of Luce­myra, a pill that helps pa­tients man­age symp­toms of with­draw­al.

The drug, which has been used in the Unit­ed King­dom for more than two decades now, is made by Louisville, KY-based US WorldMeds. The spe­cial­ty phar­ma was not grant­ed ap­proval to treat opi­oid use dis­or­der, but in­stead to treat symp­toms of with­draw­al.

Scott Got­tlieb

For those ad­dict­ed to opi­oids, quit­ting cold turkey can be a har­row­ing ex­pe­ri­ence. In as lit­tle as a few hours, pa­tients may ex­pe­ri­ence stom­ach cramps, mus­cle aches and spasms, a pound­ing heart, nau­sea, vom­it­ing and di­ar­rhea. Oth­er symp­toms in­clude anx­i­ety, ag­i­ta­tion, de­pres­sion and in­som­nia.

The NIH says these symp­toms aren’t di­rect­ly life-threat­en­ing, but they can dri­ve the pa­tient back to opi­oid use — of­ten over­dos­ing af­ter ex­pe­ri­enc­ing with­draw­al.

“We know that the phys­i­cal symp­toms of opi­oid with­draw­al can be one of the biggest bar­ri­ers for pa­tients seek­ing help and ul­ti­mate­ly over­com­ing ad­dic­tion,” said FDA com­mis­sion­er Scott Got­tlieb in a state­ment. “The fear of ex­pe­ri­enc­ing with­draw­al symp­toms of­ten pre­vents those suf­fer­ing from opi­oid ad­dic­tion from seek­ing help. And those who seek as­sis­tance may re­lapse due to con­tin­ued with­draw­al symp­toms.”

Sharon Hertz

Luce­myra (lofex­i­dine hy­drochlo­ride) was orig­i­nal­ly in­tend­ed to be a hy­per­ten­sion drug. It re­duces the re­lease of nor­ep­i­neph­rine, a hor­mone be­lieved to play a key role in trig­ger­ing with­draw­al symp­toms. In two ran­dom­ized, dou­ble-blind, place­bo-con­trolled tri­als, 866 adult pa­tients demon­strat­ed the ben­e­fits and safe­ty of the drug. Com­pared to the place­bo group, pa­tients treat­ed with Luce­myra re­port­ed a low­er sever­i­ty of symp­toms. Plus, pa­tients who got Luce­myra were more like­ly to com­plete the course of treat­ment, which can on­ly last for up to 14 days.

The FDA is re­quir­ing 15 ad­di­tion­al stud­ies to fur­ther as­sess the drug’s safe­ty when used in chil­dren, for longer than 14 days, and in oth­er sit­u­a­tions that were not test­ed in the ear­li­er tri­als.

It will be in­ter­est­ing to see whether a drug like Luce­myra com­petes or is used in tan­dem with drugs like Sublo­cade, the in­jectable ver­sion of In­di­v­ior’s pop­u­lar opi­oid use dis­or­der drug Sub­ox­one. Sublo­cade, a month­ly in­jec­tion of buprenor­phine, con­tains a mild opi­oid to help stymie with­draw­al symp­toms for ad­dicts quit­ting opi­oid use.

Sublo­cade is ap­proved to treat opi­oid abuse dis­or­der, but it al­so con­tains opi­oids itelf. Some pa­tients — or doc­tors — may pre­fer an op­tion like Luce­myra to ease with­draw­al symp­toms, as it the drug does not con­tain opi­oids.

“To­day’s ap­proval rep­re­sents the first FDA-ap­proved non-opi­oid treat­ment for the man­age­ment of opi­oid with­draw­al symp­toms and pro­vides a new op­tion that al­lows providers to work with pa­tients to se­lect the treat­ment best suit­ed to an in­di­vid­ual’s needs,” said Sharon Hertz, di­rec­tor of the Di­vi­sion of Anes­the­sia, Anal­ge­sia and Ad­dic­tion Prod­ucts at the FDA.

John Hood [file photo]

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