1st pill aimed at boost­ing fe­male li­bido OK’d Q&A: 1st pill ap­proved to boost fe­male sex drive

The China Post - - LIFE GUIDE POST -

The U.S. Food and Drug Ad­min­is­tra­tion (FDA) has ap­proved the first pre­scrip­tion drug de­signed to boost sex­ual de­sire in women, a mile­stone long sought by a phar­ma­ceu­ti­cal in­dus­try ea­ger to repli­cate the block­buster suc­cess of im­po­tence drugs for men.

But strin­gent safety mea­sures on the daily pill called Ad­dyi mean it will prob­a­bly never achieve the sales of Vi­a­gra, which has gen­er­ated bil­lions of dol­lars since the late 1990s.

The drug’s la­bel will bear a boxed warn­ing — the most se­ri­ous type — alert­ing doc­tors and pa­tients to the risks of dan­ger­ously low blood pres­sure and faint­ing, es­pe­cially when the pill is com­bined with al­co­hol. The same prob­lems can oc­cur when tak­ing the drug with other com­monly pre­scribed med­i­ca­tions, in­clud­ing an­ti­fun­gals used to treat yeast in­fec­tions.

“Pa­tients and pre­scribers should fully un­der­stand the risks as­so­ci­ated with the use of Ad­dyi be­fore con­sid­er­ing treat­ment,” said Dr. Janet Woodcock, di­rec­tor of the FDA’s drug cen­ter, in a state­ment an­nounc­ing the ap­proval Tues­day.

Un­der an FDA-im­posed safety plan, doc­tors will only be able to pre­scribe Ad­dyi af­ter com­plet­ing an online cer­ti­fi­ca­tion process that re­quires coun­sel­ing pa­tients about Ad­dyi’s risks. Phar­ma­cists will also need cer­ti­fi­ca­tion and will be re­quired to re­mind pa­tients not to drink al­co­hol while tak­ing the drug.

Op­po­nents of the drug say it’s not worth the side ef­fects, which also in­clude nau­sea, drowsi­ness and dizzi­ness. They point out that the FDA re­jected the drug twice, in 2010 and 2013, due to these risks.

“This is not a drug you take an hour be­fore you have sex. You have to take it for weeks and months in or­der to see any ben­e­fit at all,” said Leonore Tiefer, a psy­chol­o­gist and sex ther­a­pist who or­ga­nized a pe­ti­tion last month call­ing on the FDA to re­ject the drug.

Pa­tients should stop tak­ing the drug af­ter eight weeks if they do not see any im­prove­ment, notes the FDA re­lease.

Sprout Phar­ma­ceu­ti­cal’s drug is in­tended to treat women who re­port emo­tional stress due to a lack of li­bido. Its ap­proval marks a turn­around for the FDA, which pre­vi­ously re­jected the drug twice due to lack­lus­ter ef­fec­tive­ness and side ef­fects. The de­ci­sion rep­re­sents a com­pro­mise of sorts be­tween two camps that have pub­licly feuded over the drug for years.

On one side, Sprout and its sup­port­ers have ar­gued that women des­per­ately need FDA-ap­proved medicines to treat sex­ual prob­lems. On the other side, safety ad­vo­cates and phar­ma­ceu­ti­cal crit­ics warn that Ad­dyi is a prob­lem-prone drug for a ques­tion­able med­i­cal con­di­tion.

Be­gin­ning with the drug’s launch in mid-Oc­to­ber, doc­tors who see pa­tients com­plain­ing about a loss of sex­ual ap­petite will have a new op­tion.

“Women are grasp­ing, and I feel like we need to of­fer them some­thing that ac­knowl­edges that, and that we can feel safe and com­fort­able with,” said Dr. Ch­eryl Igle­sia, a sur­geon and of­fi­cial with the Amer­i­can Congress of Ob­ste­tri­cians and Gyne­col­o­gists. Igle­sia said she has oc­ca­sion­ally re­sorted to pre­scrib­ing testos­terone creams to boost women’s li­bido, a use not ap­proved by the FDA.

The search for a pill to treat women’s sex­ual dif­fi­cul­ties has been some­thing of a holy grail for the phar­ma­ceu­ti­cal in­dus­try. It was pur­sued and later aban­doned by Pfizer, Bayer and Proc­ter & Gam­ble, among oth­ers. But drugs that act on blood flow, hor­mones and other bi­o­log­i­cal

U.S. fed­eral health of­fi­cials on Tues­day ap­proved the first-ever pre­scrip­tion drug in­tended to treat women suf­fer­ing from a lack of sex­ual de­sire, end­ing a vig­or­ous de­bate over the drug’s fate.

The daily pill, called Ad­dyi, comes with warn­ings about risks of faint­ing if it is com­bined with cer­tain other drugs or al­co­hol. Ad­di­tion­ally, doc­tors won’t be able to pre­scribe it un­less they com­plete an online cer­ti­fi­ca­tion test.

Here’s a look at the new drug from Sprout Phar­ma­ceu­ti­cals:

How Does It Work?

Ad­dyi, known gener­i­cally as flibanserin, acts on brain chem­i­cals as­so­ci­ated with mood and ap­petite, sim­i­lar to an­tide­pres­sant drugs. In fact, it was orig­i­nally stud­ied as a treat­ment for de­pres­sion be­fore be­ing re­pur­posed into a li­bido drug. It’s not en­tirely clear why the drug in­creases sex­ual de­sire but re­searchers point to its abil­ity to in­crease dopamine — a brain chem­i­cal as­so­ci­ated with ap­petite — while low­er­ing sero­tonin — another chem­i­cal linked with feel­ings of sa­ti­a­tion.

Who Will Take This Drug?

The U.S. Food and Drug Ad­min­is­tra­tion (FDA) ap­proved Ad­dyi func­tions all proved in­ef­fec­tive.

Ad­dyi, known gener­i­cally as flibanserin, is the first drug that acts on brain chem­i­cals that af­fect mood and ap­petite.

Women and their doc­tors will have to de­cide whether the drug’s mod­est ben­e­fits war­rant tak­ing a psy­chi­atric pill on a daily ba­sis. for pre­menopausal women with hy­poac­tive sex­ual de­sire dis­or­der, de­scribed as a lack of sex­ual ap­petite that causes emo­tional dis­tress.

Sur­veys es­ti­mate that be­tween 5.5 mil­lion to 8.6 mil­lion U.S. women have the con­di­tion, or roughly 8 to 14 per­cent of women ages 20 to 49. Be­cause so many other fac­tors af­fect sex­ual ap­petite, there are a num­ber of al­ter­nate causes doc­tors must rule out be­fore di­ag­nos­ing the con­di­tion, in­clud­ing re­la­tion­ship prob­lems, med­i­cal con­di­tions and mood is­sues caused by other med­i­ca­tions like sleep­ing aids and painkillers.

The di­ag­no­sis is not uni­ver­sally ac­cepted and many psy­chol­o­gists ar­gue that low sex drive should not be con­sid­ered a med­i­cal con­di­tion.

I’ve Heard This De­ci­sion Was

Con­tro­ver­sial, Why?

The drug fol­lowed a long, con­tentious path to ap­proval, in­clud­ing two pre­vi­ous re­jec­tions by the FDA. For years, two op­pos­ing sides have ar­gued over the fate of the drug.

On one hand, drug­mak­ers and some med­i­cal ex­perts ar­gue that women need FDA-ap­proved med­i­ca­tions to treat sex­ual dis­or­ders, which they con­sider se­ri­ous med­i­cal prob­lems. On the other side,

Com­pany tri­als showed women tak­ing the drug gen­er­ally re­ported one ex­tra “sex­u­ally sat­is­fy­ing event” per month, and scored higher on ques­tion­naires mea­sur­ing de­sire.

Tiefer and other crit­ics said the FDA was pres­sured into ap­prov­ing the drug by a fem­i­nist-themed lob­by­ing cam­paign funded by Sprout con­sumer-safety ad­vo­cates have said the drug’s side ef­fects are too risky, and there are those who ques­tion whether low li­bido is a med­i­cal con­di­tion.

On top of this de­bate, Sprout Phar­ma­ceu­ti­cals en­listed out­side politi­cians and women’s groups to lobby the FDA to ap­prove the drug.

Does the Drug Work?

Ex­perts usu­ally de­scribe Ad­dyi’s ef­fect as “mod­est.” In com­pany stud­ies, women tak­ing flibanserin re­ported a slight in­crease in sex­u­ally sat­is­fy­ing events each month. Their an­swers to sep­a­rate ques­tion­naires in­di­cated they ex­pe­ri­enced a slight in­crease in de­sire and a slight de­crease in stress.

While FDA sci­en­tists de­scribe these ef­fects as “small,” they were sig­nif­i­cant enough to meet FDA ef­fec­tive­ness stan­dards.

What Are the Side Ef­fects?

About 10 per­cent of pa­tients in Sprout’s stud­ies ex­pe­ri­enced the most com­mon prob­lems: dizzi­ness, fa­tigue and nau­sea. The drug will also bear a boxed warn­ing that women should not drink or take cer­tain types of other med­i­ca­tions, in­clud­ing an­ti­fun­gal drugs, be­cause of an in­ter­ac­tion that can cause low blood pres­sure and other drug­mak­ers.

“It’s just a mish­mash of pol­i­tics and science and sex and money,” Tiefer said.

The lob­by­ing group, dubbed Even the Score, be­gan pub­li­ciz­ing the lack of drugs for fe­male sex­ual dys­func­tion as a women’s rights is­sue last year.

“Women de­serve equal treat-

and faint­ing.

How Much Will It Cost?

Sprout says women who have health in­sur­ance will pay be­tween US$30 and US$75 for a month’s sup­ply of Ad­dyi, depend­ing on their cov­er­age terms.

Why Did the FDA Ap­prove Ad­dyi

This Time Around?

When FDA reg­u­la­tors first re­jected Ad­dyi in 2010 they noted that the drug failed to achieve a key study goal — in­creas­ing de­sire based on pa­tients’ daily jour­nal en­tries. Be­cause of that lack of ef­fec­tive­ness, they said, the drug’s neg­a­tive side ef­fects out­weighed its ben­e­fits.

Since then, Sprout con­ducted another study of sex­ual de­sire us­ing a dif­fer­ent method that achieved sta­tis­ti­cal sig­nif­i­cance. The com­pany also con­ducted sev­eral safety stud­ies to more clearly de­fine the drug’s risks, which are out­lined in its warn­ing la­bel.

While the FDA is re­quired to make all de­ci­sions based on science, crit­ics say that the con­certed lob­by­ing ef­fort by Sprout-funded sup­port­ers also played a role in Ad­dyi’s ap­proval.

When Will the Drug Be

Avail­able?

Sprout plans to launch the drug in mid-Oc­to­ber. ment when it comes to sex,” the group states in an online pe­ti­tion to the FDA, which at­tracted more than 60,000 sup­port­ers. Women’s groups, in­clud­ing the Na­tional Or­ga­ni­za­tion for Women, signed on to the ef­fort, though it was funded by Sprout and other com­pa­nies work­ing on fe­male sex drugs.

AP

In this June 22 photo, a tablet of flibanserin sits on a brochure for Sprout Phar­ma­ceu­ti­cals in the com­pany’s Raleigh, North Carolina head­quar­ters. The U.S. Food and Drug Ad­min­is­tra­tion, Tues­day, Aug. 18, ap­proved the first pre­scrip­tion drug de­signed to boost sex­ual de­sire in women, a mile­stone long sought by a phar­ma­ceu­ti­cal in­dus­try ea­ger to repli­cate the block­buster suc­cess of im­po­tence drugs for men.

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