FDA Panel Votes to Approve ‘Female Viagra’ With Conditions After Third Hearing

The FDA is set to make a final decision in August, and while the agency generally follows to the panelists’ vote, it is not bound to adhere to it.

Medical experts from the FDA examined the evidence on the effectiveness of the drug flibanserin, designed to help pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD).

This is the third time the drug has been presented to the FDA, after previous attempts to get the drug approved failed in part due to the agency having concerns about whether its benefits outweighed the risks.

A mother and her daughter were among those to offer emotional testimony to the FDA panel today. The mother, Barbara, talked about how her relationships with her husband and family became strained because of her lack of a sex drive. She said she was diagnosed with HSDD and told the panel that she was “so relieved to know this was not my fault.” She was on the clinical trial and said the results were dramatic, “no negative side effects, just good ones, really good ones.” 

But then she spoke about her daughter and her pain in knowing that she passed this condition down to Vikki. Then her daughter, with voice cracking, told the panel that “divorce is on the table.” Despite her efforts to be sexual, “my husband thinks I don’t love him anymore.”

The drug works by manipulating chemicals in the brain to try and induce sexual desire and was originally designed as an antidepressant.

Early studies showed the drug helped women have more “satisfying sexual events,” the FDA stated in a summary released before the meeting, but those who took the drug also faced multiple side effects, including nausea, dizziness, fatigue and fainting — though very rare, according to proponents. During the early testing, the drug failed to show improvement in the key outcome of improving sexual desire. In addition, long-term effects from a drug taken every single day are a big unknown and one that may still give the FDA pause.

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