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Third Time Lucky: FDA Panel Approval of Female Viagra

by Kelly King RN C, BSN on June 30th, 2015

Did you know that approximately 43% of women experience some sort of sexual dysfunction?

On June 4, 2015, manufacturer of flibanserin “female Viagra”, Sprout Pharmaceuticals, Inc., made a significant stride in being able to market flibanserin in the United States. A key advisory panel to the Food and Drug Administration (FDA) recommended approving the medication for treating premenopausal Hypoactive Sexual Desire Disorder.

What Is Hypoactive Sexual Desire Disorder?

Sexual dysfunction in women manifests itself via lack of desire, arousal or orgasm. Lack of desire seems to be the most common complaint, arising from fatigue, family or relationship issues, financial or job concerns and childcare duties, among others factors.  The medical definition of Hypoactive Sexual Desire Disorder is “a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not accounted for by medical, substance-related, psychiatric (e.g., depression) or other sexual condition.”

What Treatment Options do Women Have?

Pharmaceutical companies are intent on developing medication(s) that will increase blood flow to the female genitals, for purposes of relaxing genital muscle tissue and promoting vaginal lubrication. The female alternatives to Viagra are as follows:

  • DHEA-also known as Dehydroepiandrosterone, is a male hormone produced by the adrenal gland and ovaries, and then changed into testosterone and estrogen. Unfortunately, the use of this supplement can cause breast cancer and heart attacks, in addition to other debilitating side effects.
  • L-arginine Amino Acid Cream– L-arginine is an amino acid that is converted in the body into a chemical called nitric oxide. Nitric oxide causes blood vessels to open wider for improved blood flow. The supplement has been utilized in athletes to improve muscle development.
  • Testosterone Therapy- a testosterone patch has been developed for use in women that have undergone a total hysterectomy (with ovary removal); however, this has not received FDA approval

Medication Mechanics

Flibanserin works differently than male Viagra. Male Viagra works as a vasodilator, which increases blood flow, thereby resulting in swelling of the penile tissue.

Flibanserin focuses on neurotransmitters-increasing dopamine and norepinephrine, which control sexual excitement. The medication also decreases levels of serotonin, which is responsible for sexual inhibition. Studies show that sexual desire in women is closely linked to emotional, rather than physical factors. Currently, there are approximately 24 drugs for men that either treat erectile dysfunction or replace testosterone, and none for women to increase sexual desire.

Journey to FDA Approval

Sprout Pharmaceuticals, Inc. began its quest toward FDA approval of flibanserin in 2010, at which time it was rejected due to effectiveness and safety concerns. The medication was resubmitted for FDA approval in October 2013, and was again rejected due to the same issues.

The manufacturer filed a Formal Dispute Resolution with the FDA in December 2013, which gave rise to “clear guidance from the FDA on the path forward”. Sprout Pharmaceuticals, Inc. then completed a Phase 1 pharmacokinetic study and a Phase 1 driving study, at the request of the FDA. The results of these studies were included within the manufacturer’s resubmission package to the FDA in February 2015.

Flibanserin had, by this time, been evaluated in “three pivotal Phase 3, randomized, double-blind, placebo-controlled, parallel-group studies”. Premenopausal women with a mean age of 36 years reported statistically significant results, including:

  • Increased sexual desire,
  • Reduction in anguish, resulting from the loss of sexual desire, and
  • An upturn in the occurrence of satisfying sex.

Third Time Charm?

Now that flibanserin has been recommended for approval in treatment, Sprout Pharmaceuticals must develop safety plan to manage side effects, such as fatigue, low blood pressure and fainting.

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