The Advisory Committee of the US Food and Drug Administration (FDA) voted 18 to 6 to recommend that the FDA approve Flibanserin for enhancing sexual desire in pre-menopausal women suffering from female hypoactive sexual desire disorder (HSDD). The committee’s positive recommendation is conditional, in that women are made aware of the medicine’s adverse side effects such as accidents occurring as a result of combining the drug with alcohol, low blood pressure, fainting, etc. The FDA is not bound by the recommendation of the Advisory Committee, although, in most cases, the agency does follow the committee’s advice.
According to the North American Menopause Society, HSDD is the most prevalent sexual disorder in women of all ages. Simply put, if a woman has little interest in sex that causes her distress and interpersonal difficulty, she is said to have HSDD, although the diagnosis may not be that simple. HSDD has thus far has been a difficult condition to diagnose and treat, as there could be many causes and contributing factors such as a woman’s age, recent changes in medical condition, dissatisfaction with a partner, pregnancy, childbirth, pre-existing sexual dysfunction, etc. Both hormonal and non-hormonal treatments have been suggested for treating HSDD in women.
Flibanserin is a drug that acts on the brain neurotransmitters: dopamine, serotonin, and norepinephrine. The medicine increases the levels of dopamine and norepinephrine while decreasing the levels of serotonin. Owing to concerns about its efficacy, as well as drug safety issues, the FDA rejected the marketing authorization twice for the drug. However, the manufacturer conducted more research and re-submitted the information to the FDA. Based on the collective data, the FDA advisory committee concluded that women using the drug reported a modest increase in satisfactory sexual events when compared to women on placebo.
There are concerns about Flibanserin:
- The improvement in satisfactory sexual event reported is, at best, modest (from 2 or 3 events with no medicine, the median improvement of satisfactory events following drug intake is reported to be 0.5 to 1.0).
- The medicine needs to be used daily, in contrast to drugs addressing male HSDD (e.g. Viagra), which can be taken when needed.
- The desired results are not immediate and may take weeks of medication.
- The long-term effects of a powerful medicine that changes the levels of key brain chemicals/neurotransmitters are not known.
- Adverse side effects of low blood pressure, fainting, and accidents still exist.
The FDA is likely to announce its final decision by August 18, 2015. If approved, Flibanserin will represent a new class of drugs that addresses the problem of reduced sexual desire in women.
Written by Mangala Sarkar Ph.D.