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Home / Health / & # 39; Female Viagra & # 39; has just been approved by the FDA, despite "scarce, expert-verified data"

& # 39; Female Viagra & # 39; has just been approved by the FDA, despite "scarce, expert-verified data"



The Food and Drug Administration approved the sale of a new drug on Friday designed to increase women's sexual desire.

The drug is marketed as Vyleesi, also known as bromelanotide, marketed as needed in premenopausal women who suffer from stress due to low sexual desire.

"There are women who, for no known reason, have a reduced sexual desire that leads to significant discomfort and that can benefit from safe and effective pharmacological treatment," said Hylton Joffe, director of the FDA center for Drug evaluation and research into bone, reproductive and urology products, a statement states.

"Today's approval provides women with another treatment option for this disease, and as part of the FDA's commitment to protect and promote women's health, we will continue to develop safe and effective therapies for sexual dysfunction in women." [1

9659002] Julie Krop, chief medical officer of AMAG Pharmaceuticals Inc., who makes the drug, recommends using it about 45 minutes before the "expectation" of intimacy. She said the drug is a synthetic hormone that activates key brain receptors involved in sexual responses by reducing inhibition and increasing so-called neuronal arousal.

"It's not just about low sexual desire, but about how it affects the relationships and quality of patients in life," Krop said in an interview. "These women really suffer."

The drug is intended to be a treatment for hypoactive sexual desire disorder (HSDD) that the medical community recognizes can be a serious problem.

The FDA acknowledged that it is not clear how Vyleesi works in the brain to affect sexual desire or suffering. It advises women not to take more than one dose within 24 hours or eight hours a month.

And there is disagreement about whether drugs are the right approach – low sexual desire can be due to many psychological, physiological or external factors, including stress – and how widespread the condition actually is.

One study estimated that up to one in ten women had low sexual desire, and the FDA convened a meeting a few years ago to better understand the implications of women's sexual dysfunction. [19659002] Critics have pointed out that nearly all physicians in the recent jury that defined HSDD were advisors or advisory board members to Sprout Pharmaceuticals, the drug maker that also introduced the world's first female libido drug, Addyi as Flibanserin, has made known in 2015.

To Vyleesi several advocates of women's health stated that further information would be needed before the approval. They found that the FDA had not convened a review panel to review the medicine.

"It is unfortunate that the FDA chose to approve this medicine despite the tight data reviewed by experts and the lack of long-term safety information." Diana Zuckerman, President of the National Center for Health Research.

"The good news is that it does not have to be taken every day, as Addyi does, and the bad news is that the public can not trust the safety of the drug because we have no access to it Long-term safety information. "

Cynthia Pearson, executive director of the National Women's Health Network, said the group was" disappointed "by the approval and" just did not have enough information to inform themselves "decision whether to take the drug safe and effective. "

Earlier this year, Sprout caused a stir with a campaign that told women they had a" right to desire. "" Why do not we talk about it? "The ads asked Focusing on access to birth control and abortion, they questioned the idea of ​​using a civil rights language for what they essentially referred to as sales pitches.

AMAG, based in Waltham, Massachusetts, has developed its own disease awareness statement on HSDD in this Year through the "Unblush" campaign on Instagram and Facebook, which told women that "HSDD is not something they would have to blush about."

Addyi never really started, not even because it's a daily pill a While working, and the product carries a "black box" label, which warns of serious side effects such as dizziness and low blood pressure, as the drug with alcohol ol was taken.

The FDA has mitigated the warning in April to discourage women Alcohol may cause complications that need not be avoided. In May, Sprout published the results of three safety studies that seemed to support the suspicion that the association with side effects was not as clear as previously thought.

The efficacy and safety of Vyleesi was investigated in two 24-week randomized trials. Double-blind, placebo-controlled studies in more than 1,200 pre-menopausal women with HSDD.

Most patients used Vyleesi two or three times a month and at most once a week. In these studies, about 25 percent of Vyleesi-treated patients had an increase in their sexual desire, compared with about 17 percent of those taking placebo. Approximately 35 percent of patients treated with Vyleesi had a decline of one or more in their distress score, compared with about 31 percent of those who took a placebo, the FDA said. Side effects during the study included headache, blushing and nausea.

According to industry analysts, slow initial uptake of Vyleesi by consumers is expected. However, some believe that revenues will increase significantly over time, reaching as much as $ 150 million by 2030, according to Barclays.

2019 © The Washington Post

The Washington Post .


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