FDA approves ‘female viagra’ with strong restrictions

The Federal Drugs Authority (FDA) has approved Addyi (Flibanserin), nicknamed the world’s first female Viagra, aimed at treating low sexual libido in women.

Yesterday, the FDA gave the go-ahead to flibanserin, which will be sold as Addyi, a little pink pill (actually) for premenopausal women who suffer from sexual dysfunction, CNN reports. Before the new drug’s approval, the FDA had not approved any medications – for women or men – that treated sexual desire disorders.

The disorder can reportedly develop in women who previously have been sexually active.

The effects of a medication or other drug substance.

Bedtime dose the 100-mg of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, HSDD in clinical treatment.

According to The Los Angeles Times, in tests the most common side effects of the drug included dizziness, sleepiness, nausea and fatigue.

At last, after years of seeking approval from the Food and Drug Administration and performing series of trials and debates, the first ever “Female Viagra”, victory has been certified. But the latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks. Some claim the movements who pushed for the approval of the drug had co-opted the women’s movement to pressure the F.D.A. into approving a drug that was at best minimally effective. But flibanserin works in a very different way than Viagra, targeting the brain instead of genital organs.

Addyi, which was originally discovered by German drugmaker Boehringer Ingelheim, is a serotonin 1A and 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.

Nonetheless, Addyi will go on sale in October.

Also, experts said that Addyi will take at least a month-long course before showing up the results unlike a Viagra that shows instant effects.

Flibanserin had been rejected twice by the agency, while the Sprout Pharmaceuticals manufactures the drug.