FDA Approves ”Female Viagra’ pill Flibanserin after two rejections - Prometheus IP

September 5, 2015by S.L.Soujanya0

The FDA has finally approved the little pink pill to help women boost their sex drive. The approval came on the 18th of August.

Flibanserin with a dosage of 100mg developed by Sprout pharmaceuticals Inc. will be sold as Addyi. It is intended for the treatment of women diagnosed with hypoactive sexual desire disorder, HSDD.

The drug, while often referred to as “female Viagra”, is more akin to an antidepressant as it changes brain chemistry similar to the way that dopamine and serotonin do. Viagra relaxes muscles and increases blood flow to particular areas of the male body, helping treat erectile dysfunction. While the blue pill for men should be taken before engaging in sexual activity, women are to take the pink pill daily.

But the FDA has given the approval after great caution as the pill’s side effects involve lowering of blood pressure and loss of consciousness.

Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies, and the patient must be made fully aware of its consequences.

In June of this year, the pill took the first step to making it into US pharmacies. An FDA panel voted 18-6 in favor of approving Flibanserin on the condition that Sprout pharmaceutical Inc. develops a plan to limit safety risks. The panel had previously rejected the pill twice before.

In the wake of gender biasing allegations in October of last year, Sprout, along with number of organizations supporting the approval of Flibanserin, launched a campaign called “Even the Score”. The argument was that men had nearly 41 approved drugs for improvising sexual dysfunction whereas the women had none.

Experts argue that such pressures may lead to approval of risky drugs but many women argue that it is up to them as to how they would put these drugs to use.

S.L.Soujanya

Ms. S.L. Soujanya is a registered Patent agent with an academic background in Pharmaceutical sciences. She holds a Bachelor’s degree in Pharmacy from the Osmania University, Hyderabad and holds a Post Graduate Diploma in Intellectual Property Rights Law from NLSIU, Bangalore.

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