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Scoop.it!
Cindy Whitehead is the CEO who helped bring the “little pink pill” to market. 
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Scoop.it!
For the most recent FDA review, no new efficacy data were presented. Instead, the sponsor of flibanserin provided additional safety data, including a study suggesting the absence of next-day driving impairments, a comparison of the product’s adverse effect profile with that of other marketed products, and an analysis confirming the potentiating effects of alcohol on adverse events. Although the driving study was reassuring, isolated comparisons of safety across products can be misleading because FDA product reviews are not fundamentally comparative in nature. Notably, the alcohol interaction study took place in a sample of 25 healthy volunteers, only 2 of whom were women. Several additional features of the regulatory path involving flibanserin are noteworthy. First, following the FDA’s second rejection of flibanserin in 2013, an advocacy group called Even the Score was formed to advocate for what it called “gender equality” in access to treatments for sexual dysfunction. The group, initially created through the efforts of a consultant to flibanserin’s manufacturer who formerly directed the FDA’s Office of Women’s Health, promoted the claim that there are 26 approved medications for male sexual dysfunction but none for women. The claim has been rejected by the FDA, because there are no approved products for low sexual desire in men, and the 26 medications include multiple formulations of testosterone. Although flibanserin is not the first product to be supported by a consumer advocacy group in turn supported by pharmaceutical manufacturers, claims of gender bias regarding the FDA’s regulation have been particularly noteworthy, as have the extent of advocacy efforts ranging from social media campaigns to letters from members of Congress. The second noteworthy feature in the FDA application for flibanserin was the use of a patient-reported outcome of sexual desire as the primary efficacy variable for approval. Sexual desire is known only to the person experiencing it, and patient-reported outcomes measure such concepts without interpretation from others. Patient-reported outcomes are increasingly prioritized in research and other drugs have been approved with these outcomes as primary end points (although none based on sexual desire). Among all new molecular entities and biologic license applications approved by the FDA from 2006-2010, Gnanasakthy et al identified 17% (20 of 116 products) that granted patient-reported outcome claims as the primary outcome on the approved label. These features of flibanserin—the Even the Score advocacy campaign, the shifting efficacy end points and use of a patient-reported outcome measure, the tenuous risk-benefit balance among the studied population and potential for widespread off-label use, and an unmet medical need—are not totally unfamiliar territory for the FDA, but represent a challenge when they occur simultaneously. What makes the approval process for flibanserin even more unique is the politically charged atmosphere in which the FDA will decide how all these trade-offs should best be navigated.
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"Marketing won over science today," said one doctor. 1) A panel of advisers to the Food and Drug Administration just recommended the agency approve a new drug designed to boost womens' sex drives. 2) Flibanserin — a pill dubbed the 'female Viagra' — has already been rejected by the FDA twice since 2010 out of concerns that its harms outweigh its benefits. 3) The 18-6 vote is considered a "major victory" for the drug, since the FDA more often than not adopts the advice of the expert group and same panel voted unanimously against flibanserin in the past. 4) Critics have raised questions about the efficacy of flibanserin. They've also accused the pharmaceutical industry of inventing the medical condition — hypoactive sexual desire disorder — that the drug would supposedly treat.
Pharma Guy's insight:
LOL! I anticipated this result: http://sco.lt/5H0Bbl
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Since a Food and Drug Administration (FDA) advisory committee, on June 4, recommended approval of flibanserin (AddyiTM), there have been numerous editorials and news stories about the controversies surrounding the first “pink Viagra” poised to hit the market. Here, we seek to understand the process and financial incentives that led the advisory committee to recommend its approval. If approved by the FDA, Sprout Pharmaceuticals will heavily market it as a treatment for a new disorder in DSM 5: Female sexual interest/arousal disorder. Flibanserin, a serotonergic drug, was initially in clinical trials as an antidepressant. Despite its history of being a "thrice failed antidepressant," Sprout persevered and used the “finding” that some women in the drug trials said they experienced a slight increase in sexual desire as the reason to repackage the drug. Flibanserin was soon in clinical trials for Hypoactive Sexual Desire Disorder (HSDD), an indication listed in the previous edition of the Diagnostic and Statistical Manual of Mental Disorders). Sprout now maintains that HSDD is comparable to the DSM-5’s “Female Sexual Interest/Arousal Disorder,” and that women deserve a drug to treat this disorder. As part of the attempt to gain approval for its drug, Sprout initiated an ingenious marketing campaign, “Even the Score,” claiming that there was a sexism inherent in the number of FDA-approved treatments for sexual disorders: 26 for men and “zero for women.” However, this claim was false. There are only 8 drugs that treat male sexual dysfunction, and none are FDA-approved for low libido. However, the “Even the Score” campaign worked. Sprout was able to get women’s groups to sign on to the idea that getting this drug approved was almost akin to getting Title IX passed. Not surprisingly, Sprout and its marketing tactics have come under fire. Although it is easy to vilify Big Pharma or one drug manufacturer, in order to effect real change it is necessary to uncover the complex system that led the advisory committee recommend that flibanserin be approved for marketing.
Pharma Guy's insight:
Sprout is said to have promised the FDA that it won’t run Addyi TV ads for 18 months. What will it do before then to market the drug, if approved? And what will those TV ads look like? Find out here: http://bit.ly/1K2vkX8
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A federal advisory panel has recommended that the Food and Drug Administration approve the first drug to treat a lack of sexual desire in otherwise healthy women. Some women’s groups are hailing this as a breakthrough in gender equality, a start to closing the gap between men, who have numerous drugs to treat sexual dysfunction, and women, who have none. But the panel’s recommendation was laced with so many caveats that it seems clear that this particular drug — flibanserin — is only marginally effective and carries some risk of serious adverse effects. The advisory committee’s recommendation was applauded by Even the Score, a coalition of women’s groups and other organizations which is supported by Sprout, but the move was deplored by the National Women’s Health Network, which complained that Sprout had not provided enough data for women to make an informed decision. The F.D.A. should only approve the drug if strong measures are taken to reduce safety concerns.
Pharma Guy's insight:
"Women who took flibanserin, for example, reported having one more sexually satisfying event per month than women who got a placebo." - women taking 100 milligrams of flibanserin nightly reported an average of 4.5 satisfying sex acts per month, up from 2.8 acts during a four- week test period used to establish a baseline for comparison. Women taking a placebo reported 3.7 satisfying sex acts, compared to 2.7 acts during the baseline period." http://bit.ly/1MeW8X
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It's been in the works for years: a pill to help women with low sex drives. Women who've tested it love it. So, why hasn't it been approved? CBS 2's Erin Kennedy explores the controversy. Amanda Parrish, a busy working mother of four, says sex was often the last thing on her mind.
Her doctor diagnosed HSDD or hypoactive sexual desire disorder. The prescription: enter a clinical trial of flibanserin, a little pink pill designed to boost a woman’s low libido. Amanda got results. “At the end of a long day even if I had worked and even if I had gotten the kids fed there was a desire there that previously had not been there,” she said. “It actually balances out dopamine and serotonin so that women have more sexual thoughts, more fantasies,” said Northwestern Medicine’s Dr. Lauren Streicher, describing how it works in the brain.
Experts noted it didn’t work much better than a placebo and others say therapy, not a drug, should be the first choice for busy, stressed-out women. Outspoken critics, like Dr. Adriane Fugh-Berman, director of Georgetown University’s research project PharmedOut, are also concerned about side effects. “15 percent of the women in flibanserin trials dropped out because of side effects of sedation and nausea and fatigue,” Dr. Fugh-Berman. “It’s my hope that the FDA approves it. I’ll be the first in line to get it,” said Amanda Parrish. Earlier this year, Sprout Pharmaceuticals, which makes flibanserin, submitted new research on the pill’s impact on driving ability to the FDA. Those results showed no adverse effect. The FDA holds another hearing concerning the pink pill’s approval next month.
Pharma Guy's insight:
A coalition of consumer advocacy groups and drug makers launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claimed that there are more than two dozen drugs available to help men combat sexual problems, but none for women. Is FDA sexist? Read more: http://sco.lt/6zDjUn
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