There is no doubt that female sexual dysfunction (FSD) is a problem in need of solutions. FSD takes many forms. The drug Flibanserin, the so-called "female viagra" is under evaluation for treating hypoactive sexual desire disorder (HSDD). It is worth taking a moment to define HSDD.
- "Persistent or recurrently deficient (or absent) sexual fantasies and desire for sexual activity."
- This state must cause "marked distress and interpersonal difficulty "
- This state must not be caused by "another...disorder, ...a substance (e.g.drugs of abuse, a medication) or a general medical condition."
DSM IV, the Diagnostic and Statistical Manual of Mental Disorders
When the FDA evaluates a drug, it must demonstrate both safety and efficacy. After three go rounds at approval, Flibanserin has been marginal on both counts. On June 4th, during this third round, it has passed recommended from the Bone , Reproductive and Urologic Drugs Committee to the Drugs Safety, and Risk Management Advisory Committee.
Currently there are no drugs approved by the FDA to treat any form of female sexual dysfunction. There is a need. So it makes sense that Big Pharma would submit some candidate drugs.
In three different studies on Flibanserin, two primary endpoints were studied: sexual desire, and satisfying sexual endpoints (SSEs).
Study results in summary:
- SSEs increase from a baseline of 2-3 per month by 0.5-1, meaning on average, there was half to one more SSE per month when flibanserin was taken, compared to controls.
- Desire increased minimally.
- Distress regarding sexual dysfunction decreased minimally.
Concerns and side effects that surfaced:
- hypotension (abnormally low blood pressure)
- syncope (fainting)
The FDA states that concomitant use with alcohol was especially risky:
"Hypotension anad syncope can occur with Flibanserin alone and the risk is amplified by drug interactions and concomitant alcohol intake. " (reference)
So...Flibanserin does not seem like an ideal solution, but may be, like many medications, one tool in the toolbox to treat a given disorder.
Sexual function is complex and sexual dysfunction is most generally multifactorial. It may involve physical, psychological and interpersonal factors. Check with your Ob Gyn if you have challenges in this sensitive area.