F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts Mar27


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F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts

In an ef­fort to en­cour­age new treat­ments for opi­oid ad­dic­tion, the Food and Drug Ad­min­is­tra­tion plans to be­gin permitting phar­ma­ceu­ti­cal com­pa­nies to sell med­i­ca­tions that help tem­per crav­ings, even if they don’t fully stop ad­dic­tion.

The change is part of a wider ef­fort to ex­pand ac­cess to med­i­ca­tion-as­sisted treat­ment, or MAT. The agency will is­sue draft guide­lines in the next few weeks. A se­nior agency of­fi­cial pro­vided de­tails of the pro­posal to The New York Times.

The new ap­proach was sig­naled Satur­day by the health and hu­man ser­vices sec­re­tary, Alex Azar, in re­marks to the National Gover­nors As­so­ci­a­tion. Azar said the agency in­tended “to cor­rect a mis­con­cep­tion that pa­tients must achieve to­tal ab­sti­nence in or­der for MAT to be con­sid­ered ef­fec­tive.”

While Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion has gen­er­ally sup­ported med­i­ca­tion-as­sisted treat­ment, Azar’s predecessor, Tom Price, was not com­pletely on board with it. Price caused an up­roar among treat­ment ex­perts when he dis­missed some med­i­ca­tions that re­duce crav­ings through syn­thetic opi­oids last spring as sub­sti­tut­ing one opi­oid for another. He sub­se­quently walked back those com­ments, say­ing of­fi­cials should be open to a broad range of treat­ment options.

Azar, who took of­fice late last month, said he would work to re­duce the stigma as­so­ci­ated with ad­dic­tion and ad­dic­tion ther­apy, and would not treat it as a moral fail­ing.

The opi­oid epi­demic is con­sid­ered the most un­re­lent­ing drug cri­sis in U.S. his­tory. In 2016, roughly 64,000 peo­ple were killed by opi­oid-re­lated over­doses, in­clud­ing from pre­scrip­tion painkillers and heroin.

Not­ing fed­eral data show­ing that only one-third of spe­cialty sub­stance abuse treat­ment pro­grams of­fer med­i­ca­tion-as­sisted treat­ment, Azar said, “We want to raise that num­ber — in fact, it will be nigh im­pos­si­ble to turn the tide on this epi­demic with­out do­ing so.”

Azar’s com­ments echo those of the FDA chief, Dr. Scott Got­tlieb, who has made bat­tling opi­oid abuse a pri­or­ity for his agency. Got­tlieb has moved to re­duce opi­oid pre­scrip­tions by doc­tors and den­tists and to pro­mote more med­i­ca­tion-as­sisted treat­ment, de­fined as drugs used to sta­bi­lize brain chem­istry, re­duce or block the eu­phoric ef­fects of opi­oids, re­lieve phys­i­o­log­i­cal crav­ings, and nor­mal­ize body func­tions.

The FDA has ap­proved three drugs for opi­oid treat­ment — buprenor­phine (of­ten known by the brand name Subox­one), methadone and nal­trex­one (known by the brand name Viv­it­rol) — and says they are safe and ef­fec­tive com­bined with coun­sel­ing and other sup­port. But the agency said it would soon pub­lish two guid­ances — rec­om­men­da­tions for drug-makers — on the is­sue.

One en­cour­ages the de­vel­op­ment of new, longer-act­ing for­mu­la­tions of ex­ist­ing drugs for opi­oid treat­ment. The other, which was de­scribed in de­tail to The Times by an of­fi­cial who spoke anony­mously be­cause the poli­cies are be­ing fi­nal­ized and have not yet been made pub­lic, said new drugs would be el­i­gi­ble for ap­proval that don’t end ad­dic­tion but help with as­pects of it, such as crav­ings, or over­doses, with the goal re­main­ing com­plete ab­sti­nence.

From an article originally published in the New York Times.