Raleigh Drug Maker’s “Little Pink Pill” Gets FDA Thumbs Up

The drug, which is produced by Sprout Pharmaceuticals, is intended to treat sexual-health/hypoactive-sexual-desire-disorder.aspx” target=”_blank”>hypoactive sexual desire disorder (HSDD) – where a sufferer’s lack of sexual desire is causing them distress. “Today, we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition”, said Cindy Whitehead, chief executive officer of Sprout.

Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the United States.

Khera says: “These neurotransmitters do is they go to the brain and increases a woman’s desire for sex…many of these women had an increase from 2.5 to 5 or 4.5 sexual encounters in a 4 week period”.

The FDA had rejected the drug before due to the scant benefit it offered and the side-effects that came with it.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). As required by REMS, health care providers who prescribe the medication and pharmacies that dispense it are required to first complete a training program to become certified.

Food and Drug Administration (FDA) has insisted the packaging be emblazoned with prominent warnings alerting people to the potential side effects. It was only on June this year that a FDA panel voted 18-6 in favour of approving Addyi.

The drug- marketed by North Carolina-based Sprout Pharmaceuticals – can cause severely low blood pressure (hypotension) and loss of consciousness (syncope).

This drug has been developed with special focus on young pre-menopausal women who have been suffering from inability to usher optimum sexual desires. Viagra is only taken when needed before sex whereas Addyi needs to be taken once every night.

When popped after consuming alcohol, the seriousness of the side-effects becomes more acute. “Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire”, according to the AP.