accadacca
08-18-2015, 04:02 PM
A "little pink pill" designed to boost women's libido won approval from the U.S. Food and Drug Administration on Tuesday, becoming the first drug of its kind allowed on the market alongside several medications to improve sexual function in men.
"It's been a long time coming," says Cindy Whitehead, CEO of drug-maker Sprout Pharmaceuticals of Raleigh, N.C. "We're thrilled...This opens the door to medical treatment for women" never available before.
Flibanserin, which Whitehead says should hit the market by Oct. 17 under the brand name Addyi, has been dubbed "Viagra for women" even though it works very differently from the erectile dysfunction drug for men. Supporters say the new drug is a necessary option for the millions of women suffering from low sex drive, but critics question whether it's safe or effective enough.
The FDA has rejected the drug twice in the past five years, but an advisory panel of medical experts in June voted 18-6 to recommend approval if more safety restrictions were added. Panelists expressed concerns about potential side effects such as low blood pressure, fatigue and fainting, and questioned data on how the drug may interact with alcohol or birth control pills.
But supporters of the drug say the benefits may outweigh the risks for many women. U.S. Rep. Jackie Speer, D-Calif., and 10 other members of Congress signed a letter to the FDA saying: "We firmly believe that access to health care should be a fundamental right, regardless of whether you are a man or a women."
The FDA lists low libido in women as an area of unmet need in medicine, supporters point out, noting that it affects 10% of women. Flibanserin specifically aims to treat premenopausal women with Hypoactive Sexual Desire Disorder, or a lack of desire for sex that causes personal distress or difficulty in relationships.
Whitehead says the drug has been studied in more than 11,000 women, and performed better than a placebo by all measures examined. "We sort of demonstrated the benefits across the studies and characterized the risks," she says, adding that the most common side effects were dizziness, nausea and sleepiness. The sleepiness didn't impair driving the next day, she says, and fainting was related to a "challenge study" looking at how the drug interacted with alcohol. She says the drug label will include a warning about this potential interaction.
The drug has gotten a big marketing push from an advocacy group called "Even the Score," which is supported by Sprout and describes itself as "a voice for American women who believe that it's time to level the playing field when it comes to the treatment of women's sexual dysfunction."
Other campaign supporters include the National Organization for Women, the Society for Women's Health Research and the International Society for the Study of Women's Sexual Health.
The FDA dismissed accusations that it holds sexual dysfunction drugs for women to more stringent standards for approval than drugs for men. "These claims are misleading and inaccurate," the agency wrote in a June briefing document. "The FDA rejects claims of gender bias."
Some critics also argue that for all the notoriety flibanserin has gotten, it simply doesn't work that well. Women in clinical trials of the drug experienced two to three "satisfying sexual events" per month before joining the trial, and an FDA analysis showed they had 0.5 to 1 more such event per month with flibanserin compared with a placebo. Whitehead acknowledges this finding, but says "having another satisfying sexual experience can be incredibly life impacting" for patients.
Flibanserin "is either ineffective or barely effective," counters Cindy Pearson, executive director of the National Women's Health Network, adding that she's also concerned about fainting and dangerous drops in blood pressure.
Critics also point to the ways flibanserin differs from erectile dysfunction drugs such as Viagra, which is taken just before sex and increases blood flow to the genitals. Flibanserin is taken daily before bedtime and affects brain chemicals.
"The gender equity argument ignores the real safety difference between flibanserin and the drugs approved for men: a different indication for use, specifically the dosage and administration...," says a letter sent to U.S. Sen. Barbara Mikulski, D-Maryland, signed by Pearson's organization and a list of other groups and health professionals. "Given the difference between drugs administered daily and those administered on an as-needed basis, it is appropriate for the FDA to subject flibanserin to a higher level of safety scrutiny… No amount of slick marketing can obfuscate the fact that the pharmaceutical industry has yet to produce a female sexual dysfunction drug that actually works."
Kenneth Payne, an obstetrician/gynecologist with Norton OB/GYN Associates inLouisville, Ky., says he "takes exception to the aggressive marketing campaign," but would nonetheless consider prescribing the drug to patients for whom the benefits outweigh the risks.
"The jury's still a little bit out on this. Just because the FDA approves something doesn't mean it's going to work for everyone," Payne says. "What if someone's taking birth control pills? What if someone's drinking alcohol and taking this medicine? We just don't know these things...I hope it lives up to its claims."
http://www.usatoday.com/story/news/nation/2015/08/18/fda-acts--flibanserin/31840455/
"It's been a long time coming," says Cindy Whitehead, CEO of drug-maker Sprout Pharmaceuticals of Raleigh, N.C. "We're thrilled...This opens the door to medical treatment for women" never available before.
Flibanserin, which Whitehead says should hit the market by Oct. 17 under the brand name Addyi, has been dubbed "Viagra for women" even though it works very differently from the erectile dysfunction drug for men. Supporters say the new drug is a necessary option for the millions of women suffering from low sex drive, but critics question whether it's safe or effective enough.
The FDA has rejected the drug twice in the past five years, but an advisory panel of medical experts in June voted 18-6 to recommend approval if more safety restrictions were added. Panelists expressed concerns about potential side effects such as low blood pressure, fatigue and fainting, and questioned data on how the drug may interact with alcohol or birth control pills.
But supporters of the drug say the benefits may outweigh the risks for many women. U.S. Rep. Jackie Speer, D-Calif., and 10 other members of Congress signed a letter to the FDA saying: "We firmly believe that access to health care should be a fundamental right, regardless of whether you are a man or a women."
The FDA lists low libido in women as an area of unmet need in medicine, supporters point out, noting that it affects 10% of women. Flibanserin specifically aims to treat premenopausal women with Hypoactive Sexual Desire Disorder, or a lack of desire for sex that causes personal distress or difficulty in relationships.
Whitehead says the drug has been studied in more than 11,000 women, and performed better than a placebo by all measures examined. "We sort of demonstrated the benefits across the studies and characterized the risks," she says, adding that the most common side effects were dizziness, nausea and sleepiness. The sleepiness didn't impair driving the next day, she says, and fainting was related to a "challenge study" looking at how the drug interacted with alcohol. She says the drug label will include a warning about this potential interaction.
The drug has gotten a big marketing push from an advocacy group called "Even the Score," which is supported by Sprout and describes itself as "a voice for American women who believe that it's time to level the playing field when it comes to the treatment of women's sexual dysfunction."
Other campaign supporters include the National Organization for Women, the Society for Women's Health Research and the International Society for the Study of Women's Sexual Health.
The FDA dismissed accusations that it holds sexual dysfunction drugs for women to more stringent standards for approval than drugs for men. "These claims are misleading and inaccurate," the agency wrote in a June briefing document. "The FDA rejects claims of gender bias."
Some critics also argue that for all the notoriety flibanserin has gotten, it simply doesn't work that well. Women in clinical trials of the drug experienced two to three "satisfying sexual events" per month before joining the trial, and an FDA analysis showed they had 0.5 to 1 more such event per month with flibanserin compared with a placebo. Whitehead acknowledges this finding, but says "having another satisfying sexual experience can be incredibly life impacting" for patients.
Flibanserin "is either ineffective or barely effective," counters Cindy Pearson, executive director of the National Women's Health Network, adding that she's also concerned about fainting and dangerous drops in blood pressure.
Critics also point to the ways flibanserin differs from erectile dysfunction drugs such as Viagra, which is taken just before sex and increases blood flow to the genitals. Flibanserin is taken daily before bedtime and affects brain chemicals.
"The gender equity argument ignores the real safety difference between flibanserin and the drugs approved for men: a different indication for use, specifically the dosage and administration...," says a letter sent to U.S. Sen. Barbara Mikulski, D-Maryland, signed by Pearson's organization and a list of other groups and health professionals. "Given the difference between drugs administered daily and those administered on an as-needed basis, it is appropriate for the FDA to subject flibanserin to a higher level of safety scrutiny… No amount of slick marketing can obfuscate the fact that the pharmaceutical industry has yet to produce a female sexual dysfunction drug that actually works."
Kenneth Payne, an obstetrician/gynecologist with Norton OB/GYN Associates inLouisville, Ky., says he "takes exception to the aggressive marketing campaign," but would nonetheless consider prescribing the drug to patients for whom the benefits outweigh the risks.
"The jury's still a little bit out on this. Just because the FDA approves something doesn't mean it's going to work for everyone," Payne says. "What if someone's taking birth control pills? What if someone's drinking alcohol and taking this medicine? We just don't know these things...I hope it lives up to its claims."
http://www.usatoday.com/story/news/nation/2015/08/18/fda-acts--flibanserin/31840455/