Sunday, September 27

‘Viagra for Women’: FDA Approves Controversial New Drug to Boost Sex Drive

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For the second time in 5 years, every other girl model of Viagra is in its manner.
Last week, America Food and Drug Administration (FDA) approved a 2nd drug choice designed to boost low intercourse-force.
The new drug, Vyleesi, comes within the form an injection, in comparison to the sooner drug, Addy – a daily pill – and may be taken only while required in preference to being administered every day.
The drug is run like a shot into the stomach or thigh the usage of an auto-injector at least 45 mins before anticipated sexual interest, with the FDA recommending patients no longer to take multiple doses within 24 hours or greater than eight doses per month.
Palatin Technologies and AMAG Pharmaceuticals’ drug might be to be had from September onwards at pick out pharmacies. How tons a dose will fee isn’t yet recognized.
Despite the green sign for the drug, the FDA has warned that humans with high blood strain or who’ve cardiovascular sickness – or the ones at the excessive chance for cardiovascular ailment – need to no longer take it. Also, if a girl suspects she is pregnant, she has to immediately discontinue taking the drug.
During clinical trials of the drug, side consequences have been additionally mentioned – forty% of women skilled nausea after taking it. In all 18% dropped out of the trial.
The FDA, in its assertion, additionally mentioned:
“Vyleesi does now not enhance sexual performance. About 1% of patients dealt with Vyleesi in the medical trials suggested darkening of the gums and parts of the pores and skin, which includes the face and breasts, which did now not leave in approximately half the sufferers after stopping remedy.”
Analysts have said that a drug that thoroughly and efficaciously treats lack of sexual desire in women could finally attain annual sales of about $1 billion.
Vyleesi, chemically called bremelanotide, activates pathways in the mind worried in sexual desire, supporting premenopausal women with hypoactive sexual desire disease (HSDD).
“We’re glaringly pleased about being able to deliver any other choice to sufferers,” said Dr. Julie Krop, the chief clinical officer of AMAG, advised the New York Times.
“These girls have suffered notably, pretty a whole lot in silence, for a stigmatized situation, and a lot of them have now not acknowledged that it’s a treatable scientific situation.”
The American Sexual Health Association reports that 1 in 10 ladies have HSDD.
As a part of the advertising and marketing plan, AMAG has set up a website called unblush.Com that’s replete with quizzes, facts and with an ‘ask and solution’ section. Low sexual choice, the internet site says, is nothing to blush approximately.

The National Women’s Health Network has entreated ladies to keep away from the use of the drug “till more is understood about its protection and effectiveness”.
“It is vital that ladies suffering from this condition have a preference of treatment options,” Anita Clayton of the University of Virginia School of Medicine, who headed research of the drug’s safety, said in an assertion. The impact of low sexual desire, she introduced, “is going far beyond the bed room and may frequently result in tension, lack of power, shallowness troubles and courting strain.”
Vyleesi’s predecessor and competition
In 2015, the FDA had accepted Addy (flibanserin), an as soon as-every day crimson pill that turned into marketed because of the “girl Viagra”.
Addy’s manufacturer, Sprout Pharmaceuticals, was pressured to slap on a warning approximately the container approximately the aspect outcomes of the drug, particularly whilst blended with alcohol.
Aside from the warning, simplest certified doctors and pharmacies can prescribe or dispense the drug. In fact, the FDA rejected Addy twice, bringing up both small consequences and principal protection issues like low blood strain which can cause an unexpected and prolonged lack of recognition.

Unlike Viagra, which causes an erection via growing blood flow to the penis, flibanserin acts on the brain’s neurotransmitters to enhance dopamine and norepinephrine, chemical compounds associated with love and arousal. It also lowers serotonin – that may obstruct sexual desire.
Vyleesi, which does not limit alcohol use, is visible as having numerous benefits over Addai, inclusive of tolerable aspect outcomes, rapid-acting nature and no longer having to take it every day, in step with analysts.
According to funding analyst records, Addy turned into prescribed 6,000 instances closing yr, in all likelihood because of the $800 a month it set consumers again by means of. Then in 2018, Sprout slashed the fee to $400. But it’s clear Addy hasn’t observed the fanbase its makers were hoping.