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The First “Female Viagra” is FDA Approved

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Flibanserin (Addyi) has officially been FDA approved as the first “Female Viagra” – aimed at boosting the female libido. This is a non hormonal medication approved to treat pre-menopausal women for hypoactive sexual desire disorder. Sprout pharmaceuticals claims that 1 in 10 women suffer from this disorder.

Flibanserin is a 5-hydroxytryptophan (HT)(1A) receptor agonist and 5-HT(2A) receptor antagonist. This is a once daily 100mg tablet which is to be taken at bed time. If the medication has not shown to improve symptoms after 8 weeks, then it should be discontinued.

The use of alcohol has been contraindicated due to excessive dizziness and drowsiness and due to an increased risk of hypotension and syncope.

Interestingly, the DSM-5 has rid of the diagnosis hypoactive sexual desire disorder. Instead, it was merged together with other similar diagnosis as, Female Sexual Interest/Arousal Disorder – this can be characterized as a lack of desire, impaired arousal, inability to achieve orgasm, or pain with sexual activity.

The sexual problem must be recurrent or persistent and cause personal distress or interpersonal difficulty. The exact etiology is unknown.

It is not believed that oral contraception pills interfere with sexual desire, however, SSRIs and beta blockers may contribute to sexual dysfunction. Female sexual interest/arousal disorder also carries a strong association with depression and anxiety.

Flibanserin was original planned to be an antidepressant and they fought for approval in 2010. The medication was rejected and Sprout pharmaceuticals purchased the rights to the medication. They continued to appeal until the FDA finally approved the drug June 2015. The plan is to roll out the medication October 17th, 2105 and it is expected to be priced at $30 – $70 per month co-pay.

In the pivotal trial, women had a 0.5 to 1 event per month additional satisfying sexual event (over baseline), and a 0.3 to 0.4 improvement (on a scale of 1.2 to 6) in the Female Sexual Function Index. They also had a mean 0.3 to 0.4 improvement on the Female Sexual Distress Scale (four-point scale) compared with placebo.

50% of those taking the medication said symptoms improved. But, 38% of those taking the placebo reported the same.

It will be interesting to see what happens. There has already been a lot of controversy regarding the release of the “female viagra”.