FDA ap­proves first drug for post­par­tum de­pres­sion

The Buffalo News - - NATIONAL NEWS - By Pam Belluck

The first drug for women suf­fer­ing post­par­tum de­pres­sion re­ceived fed­eral ap­proval on Tues­day, a move likely to pave the way for a wave of treat­ments to ad­dress a de­bil­i­tat­ing con­di­tion that is the most com­mon com­pli­ca­tion of preg­nancy.

The drug, a syn­thetic ver­sion of a nat­u­rally oc­cur­ring hor­mone, may be a sig­nif­i­cant im­prove­ment over cur­rently avail­able an­tide­pres­sants be­cause it works very quickly, within 48 hours.

That may be es­pe­cially help­ful in cir­cum­stances where de­pres­sion keeps mothers from pro­vid­ing their ba­bies with the care, bond­ing and nur­tur­ing that is cru­cial for healthy de­vel­op­ment. Most an­tide­pres­sants take two to four weeks to ease symp­toms, if they work at all.

“Post­par­tum de­pres­sion is a se­ri­ous con­di­tion that, when se­vere, can be life-threat­en­ing,” Dr. Tif­fany Far­chione, act­ing di­rec­tor of the Divi­sion of Psy­chi­a­try Prod­ucts at the Food and Drug Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion and Re­search, said in a state­ment.

“This ap­proval marks the first time a drug has been specif­i­cally ap­proved to treat post­par­tum de­pres­sion, pro­vid­ing an im­por­tant new treat­ment op­tion.”

There are lim­i­ta­tions to the new drug, brex­anolone, which will be mar­keted as Zul­resso. It is de­liv­ered by in­fu­sion over 60 hours, dur­ing which a new mother must re­main in a cer­ti­fied med­i­cal cen­ter, un­der su­per­vi­sion should she get dizzy or faint, as sev­eral pa­tients did in clin­i­cal tri­als.

The in­fu­sion will be ex­pen­sive, be­tween $20,000 and $35,000, not in­clud­ing the costs of stay­ing in the med­i­cal cen­ter for 2½ days.

A pill ver­sion, which would be much more ac­ces­si­ble and eas­ier for pa­tients, is show­ing prom­ise in its clin­i­cal tri­als and would be sub­mit­ted for ap­proval in a cou­ple of years if the re­sults are good, ac­cord­ing to the man­u­fac­turer, Sage Ther­a­peu­tics.

The in­fu­sion is to be ad­min­is­tered just once, and pa­tients may also take stan­dard an­tide­pres­sants. Com­pany of­fi­cials say they ex­pect that in­sur­ers will cover the treat­ment; in­sur­ers said this week that they are eval­u­at­ing the drug.

Clin­i­cal tri­als of the drug, all spon­sored by Sage, found that it pro­duced a steeper de­crease in symp­toms in women with se­vere and mod­er­ate post­par­tum de­pres­sion than a sim­i­lar placebo in­fu­sion.

The relief from de­pres­sion con­tin­ued for a month af­ter the treat­ment. While there were anec­do­tal re­ports that it ex­tended be­yond that pe­riod for some women, there has not been sys­tem­atic re­search on longer-term re­sults.

“The ma­jor thing is, of course, the rapid ef­fect,” said Dr. Mar­garet Spinelli, a clin­i­cal pro­fes­sor of psy­chi­a­try at Columbia Univer­sity, who treats and stud­ies post­par­tum de­pres­sion and was not in­volved in the re­search on brex­anolone.

“That it’s the first that’s de­signed for post­par­tum de­pres­sion is im­por­tant and means it will prob­a­bly be a segue to de­sign other med­i­ca­tions for post­par­tum de­pres­sion to be ad­min­is­tered in an eas­ier way,” she added.

The treat­ment may be help­ful for up to 30 per­cent of the 400,000 Amer­i­can women who de­velop post­par­tum de­pres­sion each year, said Dr. Kim­berly Yonkers, a pro­fes­sor of psy­chi­a­try, ob­stet­rics-gy­ne­col­ogy and re­pro­duc­tive sci­ences at Yale, who was not in­volved in the re­search.

Can­di­dates for treat­ment would likely be those ex­pe­ri­enc­ing se­vere symp­toms or who failed to im­prove on stan­dard an­tide­pres­sants, Yonkers said.

“This brings up a lot of very com­plex pub­lic health is­sues,” she added, not­ing the ex­pense of the treat­ment and the need for pa­tients to be ad­mit­ted to med­i­cal cen­ters.

“It may be worth it, if some­body has been treat­ment-re­sis­tant or they can’t wait the two to four weeks for an an­tide­pres­sant to kick in,” Yonkers said. “De­pres­sion can be pretty mis­er­able,” she added, harm­ing the en­tire fam­ily.

Stephanie Hath­away, 33, a mother of two in South Wind­sor, Conn., had no his­tory of de­pres­sion. But af­ter giv­ing birth to her daugh­ters – Hadley, 4, and Bren­ley, 2 – she be­gan cry­ing non­stop, and lost in­ter­est in do­ing things she loved, like cook­ing and so­cial­iz­ing.

“I start­ing hav­ing in­tru­sive thoughts that would not go away,” she re­called. “‘Your daugh­ter de­serves a bet­ter mom, and your hus­band de­serves a bet­ter wife’ – that would just play on re­peat.”

Ul­ti­mately Hath­away felt sui­ci­dal and feared she would harm her­self if she stopped hold­ing the baby. Af­ter Hadley’s birth, Hath­away, then liv­ing with her hus­band in China, spent two weeks un­der round-the-clock sui­cide watch at home.

The an­tide­pres­sant she was pre­scribed, Zoloft, took three months, at in­creas­ing dosages, to elim­i­nate her symp­toms. Fol­low­ing Bren­ley’s birth, Zoloft didn’t help at all, Hath­away said, so about five months af­ter­ward, she vol­un­teered for the brex­anolone trial.

Be­tween 12 and 18 hours af­ter the in­fu­sion started, “I ac­tu­ally woke up from a nap and those in­tru­sive thoughts that played on re­peat, they were gone,” Hath­away said.

Af­ter leav­ing the hos­pi­tal, “I felt like my­self again,” Hath­away said. “I’m not go­ing to say I was 100 per­cent, but I will say there was so much less of a gap to get there.”

She did not stop an­tide­pres­sants al­to­gether, but switched to a low dose of Ef­fexor.

Dizzi­ness and sleepi­ness were the most com­mon side ef­fects in the tri­als, each af­fect­ing about 1 in 8 pa­tients, in­clud­ing Hath­away. The most wor­ri­some ef­fect, the FDA said, was fainting or tem­po­rary loss of con­scious­ness, seen in five pa­tients. All re­cov­ered within an hour and re­sumed get­ting the in­fu­sion.

Brex­anolone is a syn­thetic form of al­lo­preg­nanolone, a hor­mone pro­duced by pro­ges­terone in the brain that may help ease de­pres­sion and anx­i­ety by damp­en­ing neu­ral ac­tiv­ity, said Dr. Saman­tha Meltzer-Brody, di­rec­tor of the peri­na­tal psy­chi­a­try pro­gram at the Univer­sity of North Carolina at Chapel Hill, who was the prin­ci­pal in­ves­ti­ga­tor for the brex­anolone stud­ies.

The re­search pre­sented to the FDA con­sisted of three clin­i­cal tri­als that were led by Meltzer-Brody and funded by Sage Ther­a­peu­tics, which was also in­volved in the study de­sign, data anal­y­sis, in­ter­pre­ta­tion and writ­ing of the re­ports.

The tri­als in­volved 247 women ran­domly se­lected to re­ceive a placebo or brex­anolone – a rel­a­tively small num­ber of par­tic­i­pants, com­pared to many other med­i­cal tri­als.

They were asked to stop breast-feed­ing dur­ing the in­fu­sion and for a few days af­ter. But Meltzer-Brody said the drug ap­pears safe for nurs­ing mothers and ba­bies, be­cause very lit­tle of it seeps into breast milk.

De­pres­sion im­proved in the women re­ceiv­ing brex­anolone and in those re­ceiv­ing placebo, a phe­nom­e­non com­mon in stud­ies of de­pres­sion treat­ments. But more women in the brex­anolone group showed im­prove­ment, and their im­prove­ment was more sub­stan­tial.

New York Times

Stephanie Hath­away with her daugh­ters Bren­ley, left, and Hadley, in South Wind­sor, Conn. Af­ter the birth of her youngest daugh­ter, Hath­away vol­un­teered for a clin­i­cal trial for the first drug for women suf­fer­ing post­par­tum de­pres­sion.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.