Four years after the United States Food and Drug Administration approved the so-called “pink Viagra” drug Addyi, intended to goose the brains of women who have lost interest in sex into a renewed sexual desire, the FDA has now given the thumbs up to a new so-called “female Viagra” that is designed to be more convenient and come with fewer side-effects than the earlier drug, which struggled to find a consumer following in the phramaceutical marketplace.
The commonly used term “female Viagra” is misleading, however, both for Addyi and the new drug, Vyleesi, which was approved earlier this week by the FDA. Viagra, or sildenafil, works simply by increasing blood flow to the penis, helping to produce erections in men who, for reasons that could be physical or psychological, experience erectile dysfunction. Viagra does not act to increase sexual desire.
Neither Vyleesi—or bremelanotide—nor its predecessor directly affect the female sexual anatomy, but instead stimulate neurological receptors in the brain that are connected to sexual desire, according to a CNN report. But the drug is not intended for use by women whose loss of sexual interest is caused by a physical condition such as menopause, or by emotional and relationship issues.
Instead, the drug is aimed at women who are diagnosed with Female Hypoactive Sexual Desire Disorder (HSDD), which according to the National Institute of Health affects about one of every three adult women, and is characterized by “a deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty.”
Unlike Addyi, which is administered in the form of a pill that must be taken daily and should not be taken in conjunction with alcohol use, Vyleesi is dispensed using a “pen” injection device, and should be injected into the thigh or abdomen about 45 minutes prior to anticipated sexual activity. But the drug is not recommended for use more than eight times in one month.
The only reported side effect is nausea, which generally ceases after a patient’s first few uses of the drug, according to a report by The Guardian.
Though the drug, which is set to hit the market in September, is designed to increase sexual interest in women, the FDA’s studies showed that Vyleesi does not cause women to crave sex on a more frequent basis. Instead, “they want better sex,” Dr. Julie Krop, chief medical officer of Amag Pharmaceuticals which developed Vyleesi, told The Associated Press.
Amag did not reveal how the new drug would be priced, but the company said that it expected some insurance plans to cover the drug.
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