BMJ 2015;350:h3097 doi: 10.1136/bmj.h3097 (Published 5 June 2015)
Page 1 of 1
News
NEWS FDA committee recommends approval for “female Viagra” Bob Roehr Washington, DC
An advisory committee of the US Food and Drug Administration voted 18 to six, on 4 June, to recommend approval of flibanserin, for the treatment of premenopausal women with hypoactive sexual desire. It is the third time that the FDA has considered the pink pill that is hoped to be the women’s version of sildenafil (Viagra). Previous advisory committees had unanimously rejected flibanserin as offering little benefit and potential risks to those who took it. Sprout Pharmaceuticals, which acquired the compound from Boehringer-Ingelheim, conducted additional work demanded by the FDA and submitted it again for consideration.
The company also instigated a “grassroots” marketing campaign for the drug that, among other things, practically accused the FDA of sexism for approving drugs for male but not for female sexual dysfunction.1 That effort was on display at the public comment portion of the meeting, where the drug’s supporters dominated the testimony. Many of them, with financial assistance from Sprout, had lobbied Congress the previous day.
Members of the advisory committee were moved by the personal stories and need for treatment for this condition. But even those members who voted for approval acknowledged that the drug’s effect was modest, about 10% better than placebo, and recommended several restrictions aimed at ensuring use only by the type of patients who participated in the studies. The trials had five pages of restrictions that excluded comorbidities and women who were taking even very commonly used drugs. No data were available on interactions with street drugs. Hypertension and syncope had occurred among the trial participants and seemed to be exacerbated by concomitant drug and alcohol use. That prompted the FDA to request a study on interactions with alcohol. Sprout responded with a new study involving 23 healthy young men and two women. Despite its
For personal use only: See rights and reprints http://www.bmj.com/permissions
feminist rhetoric, the company deemed that adequate for a drug that will be prescribed only to women.
Committee members thought this trial was inadequate and said that an additional study of drug-alcohol interactions in women was merited. They wanted to know more about the effect of flibanserin on early gestation in humans, and they recommended that providers be certified to prescribe the drug. “It’s not a little magic pink pill. There is going to be a whole lot of women with sexual dysfunction for whom there is no evidence that it is going to benefit them,” said Marjorie Shaw Phillips, a professor at the University of Georgia’s College of Pharmacy, who voted for approval. She added, “This is a situation where a patient registry would be very valuable.”
Adriane Fugh-Berman, a professor at Georgetown University’s medical school who had testified in opposition to the drug, said that flibanserin was “a mediocre aphrodisiac with some side effects.” After the vote she said, “Marketing won out over science.” The FDA does not always follow the recommendations of its advisory committees, Fugh-Berman noted. It may also impose requirements that improve knowledge of the drug and limit its ability to do harm.
thebmj.com Feature: Evening the score on sex drugs: feminist movement or marketing masquerade? (BMJ 2014;349:g6246, doi:10. 1136/bmj.g6246); Podcast: The blockbuster sex drug for women; creating a feminist issue (https://soundcloud.com/bmjpodcasts/the-sexdrug-for-women) 1
Moynihan R. Evening the score on sex drugs: feminist movement or marketing masquerade? BMJ 2014;349:g6246.
Cite this as: BMJ 2015;350:h3097 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
News
NEWS FDA committee recommends approval for “female Viagra” Bob Roehr Washington, DC
An advisory committee of the US Food and Drug Administration voted 18 to six, on 4 June, to recommend approval of flibanserin, for the treatment of premenopausal women with hypoactive sexual desire. It is the third time that the FDA has considered the pink pill that is hoped to be the women’s version of sildenafil (Viagra). Previous advisory committees had unanimously rejected flibanserin as offering little benefit and potential risks to those who took it. Sprout Pharmaceuticals, which acquired the compound from Boehringer-Ingelheim, conducted additional work demanded by the FDA and submitted it again for consideration.
The company also instigated a “grassroots” marketing campaign for the drug that, among other things, practically accused the FDA of sexism for approving drugs for male but not for female sexual dysfunction.1 That effort was on display at the public comment portion of the meeting, where the drug’s supporters dominated the testimony. Many of them, with financial assistance from Sprout, had lobbied Congress the previous day.
Members of the advisory committee were moved by the personal stories and need for treatment for this condition. But even those members who voted for approval acknowledged that the drug’s effect was modest, about 10% better than placebo, and recommended several restrictions aimed at ensuring use only by the type of patients who participated in the studies. The trials had five pages of restrictions that excluded comorbidities and women who were taking even very commonly used drugs. No data were available on interactions with street drugs. Hypertension and syncope had occurred among the trial participants and seemed to be exacerbated by concomitant drug and alcohol use. That prompted the FDA to request a study on interactions with alcohol. Sprout responded with a new study involving 23 healthy young men and two women. Despite its
For personal use only: See rights and reprints http://www.bmj.com/permissions
feminist rhetoric, the company deemed that adequate for a drug that will be prescribed only to women.
Committee members thought this trial was inadequate and said that an additional study of drug-alcohol interactions in women was merited. They wanted to know more about the effect of flibanserin on early gestation in humans, and they recommended that providers be certified to prescribe the drug. “It’s not a little magic pink pill. There is going to be a whole lot of women with sexual dysfunction for whom there is no evidence that it is going to benefit them,” said Marjorie Shaw Phillips, a professor at the University of Georgia’s College of Pharmacy, who voted for approval. She added, “This is a situation where a patient registry would be very valuable.”
Adriane Fugh-Berman, a professor at Georgetown University’s medical school who had testified in opposition to the drug, said that flibanserin was “a mediocre aphrodisiac with some side effects.” After the vote she said, “Marketing won out over science.” The FDA does not always follow the recommendations of its advisory committees, Fugh-Berman noted. It may also impose requirements that improve knowledge of the drug and limit its ability to do harm.
thebmj.com Feature: Evening the score on sex drugs: feminist movement or marketing masquerade? (BMJ 2014;349:g6246, doi:10. 1136/bmj.g6246); Podcast: The blockbuster sex drug for women; creating a feminist issue (https://soundcloud.com/bmjpodcasts/the-sexdrug-for-women) 1
Moynihan R. Evening the score on sex drugs: feminist movement or marketing masquerade? BMJ 2014;349:g6246.
Cite this as: BMJ 2015;350:h3097 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
