US panel backs fe­male li­bido pill, un­der safety con­di­tions


The drug in­dus­try’s decade-span­ning search for a fe­male equiv­a­lent to Vi­a­gra took a ma­jor step for­ward Thurs­day, as U.S. gov­ern­ment ex­perts rec­om­mended ap­proval for a pill to boost sex­ual de­sire in women.

The first-of-a-kind en­dorse­ment came with safety reser­va­tions, how­ever, due to drug side ef­fects in­clud­ing fa­tigue, low blood pres­sure and faint­ing.

The panel of Food and Drug Ad­min­is­tra­tion ad­vis­ers voted 18-6 in fa­vor of Sprout Phar­ma­ceu­ti­cal’s daily pill, flibanserin, on the con­di­tion that the com­pany de­vel­ops a plan to man­age its risks.

The rec­om­men­da­tion is a ma­jor victory for a drug some­times hailed as “fe­male Vi­a­gra,” but which has been plagued for years by con­cerns of lack­lus­ter ef­fec­tive­ness and safety is­sues. The FDA has re­jected the drug twice since 2010. And a sim­i­lar panel of FDA ex­perts voted unan­i­mously against the drug five years ago.

Thurs­day’s vote is non-bind­ing but the FDA of­ten fol­lows the ad­vice of its ex­perts. An of­fi­cial de­ci­sion is ex­pected in Au­gust.

FDA’s ex­perts ac­knowl­edged that flibanserin’s ef­fect is not very strong, but said there is a need for FDA-ap­proved drugs to ad­dress fe­male sex­ual prob­lems.

“Th­ese are very mod­est re­sults,” said Dr. Ju­lia Heiman of the Kin­sey In­sti­tute at In­di­ana Uni­ver­sity. “But on the other hand, even mod­est re­sults can make a lot of dif­fer­ence when you’re at a cer­tain point in the clin­i­cal prob­lem.”

In gen­eral, women tak­ing flibanserin re­ported be­tween 0.5 and 1 more sex­u­ally sat­is­fy­ing event per month, com­pared with women tak­ing a placebo. They also scored higher on ques­tion­naires mea­sur­ing de­sire and scored lower on mea­sures of stress.

Flibanserin, which acts on sero­tonin and other brain chem­i­cals, was orig­i­nally stud­ied as an an­tide­pres­sant, but then re­pur­posed as a li­bido pill af­ter women re­ported higher lev­els of sex­ual sat­is­fac­tion.

The ef­fort to trig­ger sex­ual in­ter­est through brain chem­istry is the drug in­dus­try’s lat­est at­tempt to ad­dress women’s sex­ual prob­lems.

Since the block­buster launch of Pfizer’s Vi­a­gra in 1998, dozens of ther­a­pies have been stud­ied for so­called fe­male sex­ual dys­func­tion, an um­brella term for var­i­ous prob­lems with li­bido, arousal and or­gasm. But prob­lems with women’s sex­ual de­sire have proven re­sis­tant to drugs that act on blood flow, hor­mones and other sim­ple bi­o­log­i­cal func­tions.

Pan­elists raised con­cerns about sev­eral safety is­sues with flibanserin, es­pe­cially low blood pres­sure and faint­ing. Those prob­lems in­creased when pa­tients com­bined the drug with al­co­hol and some com­monly-used med­i­ca­tions, in­clud­ing an­ti­fun­gal drugs. Sprout stud­ied the drug’s al­co­hol in­ter­ac­tion in a small study of 25 pa­tients, most of whom were men.

“We re­ally know al­most noth­ing about the ac­tual clin­i­cal ef­fects of us­ing this prod­uct to­gether with al­co­hol,” said Dr. To­bias Ger­hard of Rut­gers Uni­ver­sity. “We have some in­di­ca­tion that there is clearly a con­cern from very small stud­ies.”

Sev­eral pan­elists said lan­guage warn­ing of the risks of us­ing the drug with al­co­hol or with sev­eral other drugs should ap­pear on the la­bel. The com­pany should also be re­quired to ed­u­cate pre­scribers about the risk and con­duct fol­lowup stud­ies, the ex­perts said.

More than 30 public speak­ers urged the panel to back flibanserin, in­clud­ing sev­eral pa­tients who re­ceived the drug dur­ing com­pany stud­ies.

“I want to want my hus­band, it is that sim­ple,” said Amanda Par­rish, a mother of four from Nashville Tenn. “For us, flibanserin is a re­la­tion­ship-sav­ing and life-chang­ing drug.”

Many oth­ers ar­gued that the FDA has un­fairly over­looked ther­a­pies for women while ap­prov­ing sev­eral erec­tile dys­func­tion drugs for men. Sprout Phar­ma­ceu­ti­cals and other drug­mak­ers have made that claim the cen­ter of an ag­gres­sive lob­by­ing cam­paign called “Even the Score.”

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