FDA approves Addyi, controversial viagra drug for women
Addyi, the first prescription drug to enhance female sexual desire, has been approved by the FDA in the U.S.
A spokeswoman for Sprout Pharmaceuticals said the company was “committed to working closely” with worldwide regulators to make the drug available outside of the US.
It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting.
“The recent approval appears to be influenced by the company’s argument that there are 26 FDA sexual-health/fda-approves-says-no-female-viagra-n411711” target=”_blank”>approved drugs to treat various sexual dysfunctions for men but not a single one for women’s most common sexual complaint.
The drug adds to the side effects when coupled with alcohol.
The pill is meant to treat a condition called Hypoactive Sexual Desire Disorder, or chronic and distressingly low libido in premenopausal women that can not be explained by factors such as relationship troubles, stress, or medical or psychological issues.
Additionally, while men who take Viagra need only pop a pill shortly before having sex, women who use Addyi must be on a daily regimen of the medication. Addyi has to be taken every day.
HSDD is diagnosed when symptoms develop in a patient who previously had no problems with sexual desire. In addition, there is a requirement that all doctors complete a course prior to being allowed to prescribe the drug. Viagra works by stimulating blood flow to the genitalia, and does not directly affect male libido.
Created by Sprout Pharmaceuticals under the brand name Addyi, the drug received FDA approval with certain limitations.
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. The FDA rejected approval in 2010 because it considered that the benefits of taking the drug were not big enough for the risks.
Now that it’s been officially approved, it is only a matter of time until Addyi (Flibanserin) becomes available in certified pharmacies.