Pow­er­ful new opi­oid gains FDA’s ap­proval

Crit­ics fear Dsu­via will be used il­lic­itly, wors­en­ing na­tional cri­sis

Houston Chronicle Sunday - - HEALTH | SCIENCE - By Lenny Bern­stein WASH­ING­TON POST

WASH­ING­TON — The Food and Drug Ad­min­is­tra­tion ap­proved a pow­er­ful new opi­oid Fri­day for use in health care set­tings, re­ject­ing crit­i­cism from some of its own ad­vis­ers that it would in­evitably be di­verted to il­licit use and cause more over­dose deaths.

The drug is five to 10 times more po­tent than phar­ma­ceu­ti­cal fen­tanyl. The tiny pill, just 3 mil­lime­ters in di­am­e­ter, is likely to worsen the na­tion’s drug cri­sis, ac­cord­ing to crit­ics and the head of the FDA’s ad­vi­sory com­mit­tee on painkillers.

At the same time, FDA Com­mis­sioner Scott Got­tlieb is­sued an un­usual state­ment say­ing he would seek more author­ity for the agency to con­sider whether there are too many sim­i­lar drugs on the mar­ket. That might al­low the agency to turn down fu­ture ap­pli­ca­tions for new opi­oid ap­provals if the drugs are not fill­ing an un­met need.

“We need to ad­dress the ques­tion that I be­lieve un­der­lies the crit­i­cism raised in ad­vance of this ap­proval,” Got­tlieb wrote. “To what ex­tent should we eval­u­ate each opi­oid solely on its own mer­its, and to what ex­tent should we also con­sider ... the epi­demic of opi­oid mis­use and abuse that’s grip­ping our na­tion?”

As the worst drug cri­sis in U.S. his­tory has ac­cel­er­ated, agency crit­ics and some pub­lic of­fi­cials have clam­ored for that holis­tic ap­proach to nar­cotic painkillers, in­stead of the FDA’s prac­tice of eval­u­at­ing each opi­oid ap­pli­ca­tion on its own.

Got­tlieb has pledged that the FDA would do more to bal­ance ef­forts to curb the epi­demic — which killed a record 49,000 users last year, ac­cord­ing to pre­lim­i­nary data — with the needs of peo­ple who need strong pain re­lief. But Fri­day’s state­ment is the first de­tailed in­di­ca­tion of how the FDA might use its drug re­view process to tackle the over­all prob­lem.

Got­tlieb said he would bring a plan to the FDA’s Opi­oid Pol­icy Steer­ing Com­mit­tee and per­haps Con­gress. The guide­lines would al­low the agency to con­sider a nar­cotic’s ben­e­fit to pub­lic health, its risk of be­ing di­verted for in­ap­pro­pri­ate use or abuse, and its unique ben­e­fits to groups of peo­ple in pain be­fore de­cid­ing to ap­prove an opi­oid.

“In this way, (drug com­pa­nies) would know up­front where the op­por­tu­ni­ties are for de­vel­op­ing new drugs that meet the FDA’s stan­dards for safety and ef­fec­tive­ness,” he wrote.

Not in phar­ma­cies

The drug ap­proved Fri­day is a 30-mi­cro­gram pill form of sufen­tanil, a pow­er­ful, 34-year-old opi­oid com­monly used af­ter surgery and in emer­gency rooms. Each pill, placed un­der the tongue for quick ab­sorp­tion, would have the same ef­fect as 5 mil­ligrams of in­tra­venous mor­phine. Each would come in a plas­tic ap­pli­ca­tor that looks like a sy­ringe.

The drug is in­tended for use within health care set­tings and per­haps on the bat­tle­field. It would not be avail­able in re­tail phar­ma­cies.

The man­u­fac­turer, Cal­i­for­nia com­pany AcelRx, will mar­ket the drug be­gin­ning early next year un­der the name Dsu­via at a whole­sale price of $50 to $60 per dose. A spokes­woman said the com­pany is not pro­vid­ing in­for­ma­tion on ex­pected sales.

AcelRx al­ready has ap­proval for 15- and 30-mi­cro­gram ver­sions of the drug in Europe.

An FDA ad­vi­sory com­mit­tee rec­om­mended ap­proval of the new drug in a 10-3 vote Oct. 12. But Rae­ford Brown, a pro­fes­sor of anes­the­si­ol­ogy and pe­di­atrics at the Uni­ver­sity of Ken­tucky who chairs the com­mit­tee, then took the rare step of pub­licly con­demn­ing that de­ci­sion and urg­ing the FDA to re­ject the drug. Brown missed the meet­ing be­cause he was speak­ing at a med­i­cal con­fer­ence that day.

Brown, four U.S. se­na­tors and ad­vo­cacy group Pub­lic Cit­i­zen have pre­dicted that Dsu­via will be di­verted to il­licit use and cause more opi­oid over­dose deaths.

“It is cer­tain that Dsu­via will worsen the opi­oid epi­demic and kill peo­ple need­lessly,” Sid­ney Wolfe, founder of Pub­lic Cit­i­zen’s Health Re­search Group, said in a state­ment. “It will be taken by med­i­cal per­son­nel and oth­ers for whom it has not been pre­scribed. And many of those will over­dose and die.

Brown added that he has per­son­ally tried to re­sus­ci­tate health care providers who abuse sufen­tanil, “some suc­cess­fully.”

“Clearly the is­sue of the safety of the pub­lic is not im­por­tant to the com­mis­sioner, de­spite his at­tempts to ob­fus­cate and mis­di­rect,” Brown said in his joint state­ment with Pub­lic Cit­i­zen.

“To what ex­tent should we eval­u­ate each opi­oid solely on its own mer­its, and to what ex­tent should we also con­sider … the epi­demic of opi­oid mis­use and abuse that’s grip­ping our na­tion?” Scott Got­tlieb, FDA com­mis­sioner

15 years of re­search

The FDA says con­trols on drugs in­side med­i­cal fa­cil­i­ties are tight and that the great­est risk of di­ver­sion is among med­i­cal per­son­nel them­selves.

A 2016 sur­vey con­ducted by the fed­eral Sub­stance Abuse and Men­tal Health Ser­vices Ad­min­is­tra­tion shows that nar­cotics are rarely stolen from doc­tor’s of­fices, clin­ics, hospi­tals or phar­ma­cies. Fewer than 1 per­cent of peo­ple said they ac­quired opi­oids that way.

The rate of over­dose deaths among health care work­ers is rel­a­tively high, how­ever, ac­cord­ing to an Au­gust study by the Cen­ters for Dis­ease Con­trol and Pre­ven­tion, with 876 suc­cumb­ing to pre­scrip­tion opi­oids be­tween 2007 and 2012.

Hun­dreds of mil­lions of doses of pre­scrip­tion painkillers have been di­verted from the phar­ma­ceu­ti­cal sup­ply chain to il­le­gal users over the past 15 years. In many cases, il­licit users ob­tain them from friends, rel­a­tives or rogue doc­tors and phar­ma­cists, ac­cord­ing to the SAMHSA sur­vey.

One fac­tor that weighed heav­ily in the Dsu­via de­ci­sion is mil­i­tary’s in­ter­est in the drug, Got­tlieb said in his state­ment. The mil­i­tary wants to ex­plore whether the pill can be used as a bat­tle­field painkiller that is less cum­ber­some than liq­uid anal­gesics. The Pen­tagon has spent mil­lions of dol­lars help­ing to fund AcelRx’s re­search, pub­lic doc­u­ments show.

“The FDA has made it a high pri­or­ity to make sure our sol­diers have ac­cess to treat­ments that meet the unique needs of the bat­tle­field, in­clud­ing when in­tra­venous ad­min­is­tra­tion is not pos­si­ble for the treat­ment of acute pain,” Got­tlieb wrote.

Pamela Palmer, an anes­the­si­ol­o­gist, said she founded Ax­elRx to re­duce the num­ber of deaths caused by opi­oid dos­ing er­rors in hospi­tals and am­bu­la­tory care cen­ters. She said care­givers can make these mis­takes as they cal­cu­late the amount of clear liq­uid painkillers such as mor­phine to ad­min­is­ter in­tra­venously.

“The FDA ap­proval of Dsu­via is the cul­mi­na­tion of nearly 15 years of re­search to im­prove the stan­dard of care for manag­ing acute pain in med­i­cally su­per­vised set­tings,” Palmer said in a state­ment.

In­clud­ing brand name and generic drugs, there are nearly 400 opi­oids cur­rently on the mar­ket.

Craig Sherod / As­so­ci­ated Press

An image pro­vided by AcelRx Phar­ma­ceu­ti­cals shows its opi­oid Dsu­via. The drug is in­tended for use within health care set­tings and per­haps on the bat­tle­field. Dsu­via would not be avail­able in re­tail phar­ma­cies. It will be mar­keted be­gin­ning early next year.

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