‘Pink Vi­a­gra’ backed by FDA panel

Los Angeles Times - - FRONT PAGE - By Colin Diers­ing and Melissa Healy

WASH­ING­TON — Amer­i­can women may soon have ac­cess to a con­tro­ver­sial li­bido-en­hanc­ing pill dubbed “pink Vi­a­gra” af­ter a gov­ern­ment panel on Thurs­day gave its back­ing to what would be the first FDA-ap­proved drug for the treat­ment of fe­male sex­ual dys­func­tion.

In an 18-6 vote, a panel of Food and Drug Ad­min­is­tra­tion ex­perts rec­om­mended al­low­ing the ex­per­i­men­tal drug, flibanserin, to be sold in the U.S. as long as cer­tain safety pre­cau­tions are taken to min­i­mize po­ten­tial side ef­fects, which in­clude low blood pres­sure, dizzi­ness and faint­ing.

Some say drugs like flibanserin could en­hance women’s sex lives in the same way erec­tile-dys­func­tion med­i­ca­tions have im­proved men’s. But ex­perts in fe­male sex­u­al­ity scoff at the no­tion that a 100-mil­ligram pill, taken daily at bed­time, will turn women’s sex­ual de­sires on with the ease of flip­ping a light switch. In clin­i­cal tri­als, the drug had a small but mea­sur­able ef­fect.

The vote is a ma­jor victory for the drug’s owner, North Carolina-based Sprout Phar­ma­ceu­ti­cals. Two pre­vi­ous at­tempts to win ap­proval of flibanserin be­fore the same FDA com­mit­tee failed amid ques­tions about the drug’s risks and ef­fi­cacy. Though a fi­nal de­ci­sion will be made in the com--

ing months by FDA Com­mis­sioner Stephen Ostroff, the panel’s rec­om­men­da­tion is likely to weigh heav­ily.

“I think it’s a ma­jor step for­ward in bet­ter un­der­stand­ing of women’s sex­u­al­ity and bet­ter un­der­stand­ing of women be­ing able to take con­trol of their own sex­u­al­ity in a healthy way,” said Na­tional Or­ga­ni­za­tion for Women Pres­i­dent Terry O’Neill.

The de­bate over de­vel­op­ing and mar­ket­ing a pill to treat women’s sex­ual prob­lems has run for years as sci­en­tists and phar­ma­ceu­ti­cal com­pa­nies rushed to du­pli­cate the suc­cess of the block­buster drug Vi­a­gra.

Sup­port­ers of flibanserin com­plained that the FDA has ap­proved sev­eral sex­ual-dys­func­tion drugs for men, in­clud­ing Vi­a­gra, but not a sin­gle one for the mil­lions of Amer­i­can women suf­fer­ing from low li­bido. Crit­ics ac­cused the agency of a sex­ist dou­ble stan­dard.

Op­po­nents of the drug ar­gue that phar­ma­ceu­ti­cal com­pa­nies are seek­ing to profit by med­i­cal­iz­ing what they say is of­ten an emo­tional or re­la­tion­ship is­sue.

“We keep get­ting this nar­ra­tive from the drug com­pany and the pa­tients that th­ese women are un­fix­able with­out the drug,” said Thea Cac­chioni, a women’s stud-

‘I think it’s a ma­jor step for­ward in … bet­ter un­der­stand­ing of women be­ing able to take con­trol of their own sex­u­al­ity in a healthy way.’

— Terry O’Neill,

NOW pres­i­dent

ies pro­fes­sor at the Uni­ver­sity of Vic­to­ria in Canada, adding that re­search sug­gests non-phar­ma­ceu­ti­cal so­lu­tions could ad­dress some of the same is­sues.

If ul­ti­mately ap­proved, flibanserin would be the first non­hor­monal treat­ment for “hy­poac­tive sex­ual de­sire dis­or­der,” or HSDD, in pre­menopausal women. The con­di­tion aff licts some 4.8 mil­lion pre­menopausal women, but physi­cians have had es­sen­tially noth­ing to of­fer them, ac­cord­ing to Sprout.

While Vi­a­gra and sim­i­lar drugs work by in­creas­ing blood flow to cre­ate an erec­tion, f libanserin works on key chem­i­cals in the brain to stim­u­late a woman’s sex­ual de­sire.

Crit­ics are still urg­ing the FDA to re­ject the drug, cit­ing its side ef­fects and lack­lus­ter re­sults.

Chief among the safety con­cerns is ev­i­dence from clin­i­cal tri­als show­ing that some women tak­ing flibanserin are at higher risk of low blood pres­sure and faint­ing. Mem­bers of the panel were par­tic­u­larly con­cerned about the risk when flibanserin is taken with al­co­hol.

Although mem­bers of the panel sug­gested a litany of ad­di­tional safety pre­cau­tions to ac­com­pany the drug, the fi­nal de­ci­sion lies with the FDA.

In clin­i­cal tri­als, flibanserin was found to some­what in­crease the num­ber of “sex­u­ally sat­is­fy­ing events” women re­ported to re­searchers. On av­er­age, women tak­ing the drug re­ported up to one more such event per month, com­pared with women tak­ing a placebo.

At a hear­ing Thurs­day, sup­port­ers — in­clud­ing doc­tors and clin­i­cal trial par­tic­i­pants — de­fended the drug, say­ing even small im­prove­ments were im­por­tant to pa­tients.

A cou­ple of years af­ter she got re­mar­ried, Amanda Par­rish, 52, of Brent­wood, Tenn., no­ticed she no longer ini­ti­ated sex­ual con­tact with her hus­band, Ben. “A wall went up be­tween us,” she said in an in­ter­view.

About a year later, she found an HSDD pam­phlet in her doc­tor’s of­fice and joined the flibanserin trial.

“I per­son­ally was elated that there was a le­git­i­mate med­i­cal rea­son for what was go­ing on,” she said. Af­ter tak­ing the drug, her re­la­tion­ship quickly im­proved, she said. But since the trial ended, she said, the con­di­tion has re­turned, caus­ing stress and anx­i­ety.

She said she left the Thurs­day vote elated. “I ac­tu­ally said to them as we left to­day, ‘Can we all get some to take home tonight?’ ”

Sally Green­berg, ex­ecu- tive direc­tor of the Na­tional Con­sumers League, said she sup­ported ap­proval be­cause with­out an FDA-cer­ti­fied drug, women might turn to un­reg­u­lated or danger­ous sub­sti­tutes. “There is a huge un­met need for women’s low li­bido,” Green­berg said be­fore the vote.

The FDA faced a strong public cam­paign, partly or­ga­nized by Sprout, in sup­port of drug, in­clud­ing web­sites such as Even­TheScore.org and WomenDe­serve.org, char­ac­ter­iz­ing the de­bate as one of gen­der equal­ity and fair­ness.

“If you vote no to­day based on this risk, it would sig­nal that you do not be­lieve that HSDD war­rants treat­ment at all,” said Anita Clay­ton, a Uni­ver­sity of Vir­ginia pro­fes­sor who has worked as con­sul­tant for Sprout but said she had no fi­nan­cial stake in the drug. “Maybe the mes­sage is that you do not trust women with HSDD not to drink to in­tox­i­ca­tion, or you just don’t trust women.”

The drug was de­vel­oped by Ger­man phar­ma­ceu­ti­cal com­pany Boehringer In­gel­heim, which first asked the FDA in 2010 to con­sider ap­proval. An ad­vi­sory panel voted 10 to 1 to rec­om­mend against it, cit­ing scant ev­i­dence of the drug’s ef­fec­tive­ness. Sprout Phar­ma­ceu­ti­cals later ac­quired the drug from Boehringer.

Allen Breed As­so­ci­ated Press

FLIBANSERIN, a 100-mil­ligram pill taken daily at bed­time, had a small ef­fect in clin­i­cal tri­als. But crit­ics ac­cuse phar­ma­ceu­ti­cal com­pa­nies of seek­ing to profit by med­i­cal­iz­ing what they say is an emo­tional is­sue.

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