FDA Panel Votes to Approve 'Female Viagra' With Conditions After Third Hearing
By GILLIAN MOHNEY and LANA ZAK via Good Morning America
An expert panel for the U.S. Food and Drug Administration voted today to approve a drug that has been dubbed the "female Viagra" after two previous attempts failed to gain approval.
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 per-menopausal women with Hypo active 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."
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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.
The drug is produced by the pharmaceutical company Sprout. Cindy Whitehead, the founder and COO of the Raleigh, North Carolina-based company, has been fighting to get the drug approved for four years.
"There are 25 approved drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction]," Whitehead said in an interview with ABC News last year. "No matter how or why we got here, we're here, and we've got to come up with a solution for it."
The drug targets an issue more complicated than the physiological issue that men with erectile dysfunction face, according to gynecologist Dr. Lauren Streicher.
HSDD "is a very specific problem in a woman who doesn't think about sex, she doesn't fantasize, she doesn't desire sex," Streicher told ABC News last year. "What makes it different is that it's distressing to her. This has a negative impact on her. She's worried about it, she's frustrated."
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 per-menopausal women with Hypo active 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."
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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.
The drug is produced by the pharmaceutical company Sprout. Cindy Whitehead, the founder and COO of the Raleigh, North Carolina-based company, has been fighting to get the drug approved for four years.
"There are 25 approved drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction]," Whitehead said in an interview with ABC News last year. "No matter how or why we got here, we're here, and we've got to come up with a solution for it."
The drug targets an issue more complicated than the physiological issue that men with erectile dysfunction face, according to gynecologist Dr. Lauren Streicher.
HSDD "is a very specific problem in a woman who doesn't think about sex, she doesn't fantasize, she doesn't desire sex," Streicher told ABC News last year. "What makes it different is that it's distressing to her. This has a negative impact on her. She's worried about it, she's frustrated."
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