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

For the second time in 5 years, every other girl model of Viagra is in its manner.
Last week, the American Food and Drug Administration (FDA) approved a 2nd drug choice designed to boost low intercourse force.
The new drug, Vyleesi, comes in the form of an injection, in comparison to the earlier drug, Add, a daily pill, and may be taken only when required in preference to being administered every day.
The drug is run like a shot into the stomach or thigh the using an auto-injector at least 45 minutes before anticipated sexual interest, with the FDA recommending patients no longer take multiple doses within 24 hours or more than eight doses per month.
Palatin Technologies and AMAG Pharmaceuticals’ drug might be to be had from September onwards at select pharmacies. How many tons a dose will feel isn’t yet recognized.
Despite the green sign for the drug, the FDA has warned that humans with high blood pressure or who’ve cardiovascular disease, or the ones at excessive risk of cardiovascular disease, should 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 effects have been additionally mentioned – forty women skilled nausea after taking it. In all 18% dropped out of the trial.
The FDA, in its assertion, additionally mentioned:
“Vyleesi does not enhance sexual performance. About 1% of patients treated with Vyleesi in the medical trials experienced darkening of the gums and parts of the pores and skin, which includes the face and breasts, which did not improve in approximately half of the sufferers after stopping treatment.”
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 with sexual desire, supporting premenopausal women with hypoactive sexual desire disorder (HSDD).
“We’re greatly pleased about being able to deliver any other choice to sufferers,” said Dr. Julie Krop, the chief clinical officer of AMAG, as 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 not acknowledged that it’s a treatable medical situation.”
The American Sexual Health Association reports that 1 in 10 women has HSDD.
As a part of the advertising and marketing plan, AMAG has set up a website called uuunblush. Com that’s replete with quizzes, facts, and with an ‘ask and solution’ section. Low sexual choice, the website says, is nothing to blush approximately.

The National Women’s Health Network has entreated women to keep away from the use of the drug “till more is understood about its safety 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 on the drug’s safety, said in an assertion. The impact of low sexual desire, she introduced, “is going far beyond the bedroom 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 potential side effects of the drug, particularly whilst blended with alcohol.
Aside from the warning, simple 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 pressure, 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, which may obstruct sexual desire.
Vyleesi, which does not limit alcohol use, is visible as having numerous benefits over Addai, inclusive of tolerable side effects, 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 year, in all likelihood because of the $800 a month it set consumers back 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. for