You may have heard, I made the news…and, you did, too.
October 28, 2014, the FDA held a landmark 2 day conference in Silver Spring, MD. It was the first time Female Sexual Dysfunction had the government’s and the pharma world’s undivided public attention.
This event was in response to criticism that the FDA is gender imbalanced. In March 1998, Viagra was approved by the FDA for erectile dysfunction in men. Since then, a total of 24 drugs have been approved for male sexual dysfunction.
0 drugs have been approved to address female sexual dysfunction.
Some who keep score say 24-0 isn’t acceptable.
In January of this year, 4 congresswomen sent a letter to the FDA commissioner, who happens to be a woman. This letter was to bring the FDA’s attention to a gender disparity in willingness to undertake risk.
Flibanserin is a drug that was first developed by Boehringer Ingelheim. It was originally investigated as a possible anti-depressant.
Original anti-depressant studies on both men and women showed that the participants had little sexual dysfunction at the end of the trial. That’s when scientists did a happy dance. Could this possibly be the first female Viagra?
Flibanserin promotes dopamine (libido enhancing) production and dampens serotonin (libido restraint) production. There are no hormones in Flibanserin.
Flibanserin brings the brain into chemical balance between excitement and inhibition. (This is known as the ‘Kinsey dual control model.’) It would seem logical to conclude that some women with low sexual desire are heavy with the inhibition chemical, serotonin.
Flibanserin was denied approval by the FDA in October, 2010, in spite of favorable studies which proved its effectiveness and significance. 5,000 women in the US, Canada, and Europe took a 100 mg tablet once a day at bedtime. The non-placebo group went from 2.8 positive sexual experiences per month to 4.5, a 62% increase in sexual pleasure.
The FDA rejection was due to the side effects which are dizziness, nausea, fatigue, constipation and insomnia. Also, it was cited that the secondary function of enhanced sexual desire was not proven.
The 24th drug to be approved by the FDA for male sexual dysfunction, Xiaflex, has side effects of heart attack, sudden death and penile rupture (OUCH!). Viagra’s side effects include heart attack and stroke, which makes sense because it affects blood flow.
This is the reason the 4 congresswomen wrote a letter to the FDA ending with this statement, “We urge careful review employing the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation.”
After the initial FDA rejection, Boehringer Ingelheim sold Flibanserin to Sprout Pharmaceuticals, headquartered in my homestate of North Carolina. Sprout resubmitted Flibanserin for FDA consideration in June, 2013 with a total of 11,000 test subjects.
There has not been formal approval, but the FDA has given Sprout guidance. They would like to see a study on whether Flibanserin impairs a patient’s ability to drive.
In my opinion, this drug will be approved, probably within the next year. A low libido woman will need to weigh the benefit and risks to decide for herself if she wishes to pursue a chemical romance. I think this information is good to know as you begin to evaluate.
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