“Female Viagra” Approved by FDA

Sexual Dysfunction in Women

Sexual Dysfunction in Women

In August 2015, the U.S. Food and Drug Administration approved the drug fibanserin, sold by Sprout Pharmaceuticals under the brand name Addyi, for use in treating premenopausal women with a low sexual desire, called hypoactive sexual desire disorder, or HSDD. Addyi has acquired the nickname female Viagra.

Hypoactive Sexual Desire Disorder

Scientists don’t know exactly how the drug works, but they believe that it corrects a chemical imbalance in the brain that’s responsible for sexual desire in women. While it’s estimated that 40 percent of all women experience HSDD at some time in their lives, only about one in every 10 women develop the condition. HSDD can be the result of lifestyle habits or psychological factors such as stress, fatigue and mental health problems. Hormone changes can also contribute to developing HSDD.

Addyi Trials

The FDA based its approval on three trials of about 2,400 women with HSDD. The trials were randomized, double-blind and placebo-controlled, and the average age of the women was 36. Over a six week period, women in the study took either 100mg of fibanserin before bedtime or a placebo. The women taking fibanserin reported a modest increase in sexual desire and reduction in stress caused by sexual dysfunction. The most common side effects were nausea, dizziness, fatigue, sleepiness, insomnia and dry mouth.

Dangerous Potential Side Effects

Fibanserin has previously been rejected twice by the FDA because of its dangerous interaction with alcohol. When taken with alcohol, fibanserin can cause critically low blood pressure, or hypotension, and patients might lose consciousness. For this reason, health care professionals who want to prescribe the drug must complete a training program to become certified to prescribe Addyi. Only pharmacies that obtain a certification are permitted to fill the drug. Addyi contains a boxed warning that women taking Addyi should abstain from alcohol because of the risk of hypotension and concussion. Women who have liver damage and those taking moderate or strong CYP3A4 inhibitors should also not take Addyi. This includes some antibiotics, antifungals and antidepressants. The FDA ordered Sprout Pharmaceuticals to conduct three studies that focus specifically on the health risks associated with the interaction of fibanserin and alcohol.

Prescription Guidelines and Cost

The FDA warns doctors and patients to ensure that both have a clear understanding of the risks associated with taking Addyi. Patients should take a 100mg dose before bedtime, and should discontinue taking Addyi if they don’t experience any increase in sexual desire after six weeks. An Addyi prescription will cost between $30 and $75 a month for a woman who has prescription drug coverage with her health insurance.

Criticism of FDA’s Decision

Some health care professionals are criticizing the FDA’s decision to approve the drug because of its risks and because they don’t believe the trials show sufficient evidence that Addyi improves sexual desire. They accuse the FDA of giving in to¬† pressure from Sprout Pharmaceutical’s clever public relations campaign called “26-0.” Prior to Addyi’s approval, there were 26 drugs approved by the FDA to treat male sexual dysfunction and none approved to treat female sexual dysfunction. The campaign implied that the FDA was discriminating against women and their sexual health. The 26 drugs represent brands of four primary drugs approved to treat male sexual dysfunction. While these drugs help men achieve an erection, they don’t do anything to increase male sexual desire.

Outlook for Female Sexual Dysfunction Drugs

Other pharmaceutical companies are also developing drugs that work on brain receptors to increase sexual desire, and some are expected to be submitted to the FDA for approval over the next few years. The market potential for a female Viagra drug is expected to be in the billions of dollars.

STD Screenings for Sexually Active Women

Women who become sexually active should follow recommendations from the U.S. Centers for Disease Control and Prevention to get regular screenings for sexually-transmitted diseases. The CDC recommends that sexually active women get tested for chlamydia and gonorrhea at least once a year if they have multiple sex partners or a sex partner who has an STD. Pregnant women should be tested for all sexually-transmitted diseases, including hepatitis, HIV and syphilis. All women should be tested at least once for HIV.

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