Scarcity of Drugs to Treat Female Sexual Disorder Causes Concern in Medical Community

The FDA’s recent rejection of a pill to treat low sexual desire in women has led to mounting concern about the lack of available medications to treat this condition. The drug, known as flibanserin, was deemed by the FDA to have only a “modest effect” on raising female libidos, a decision which is already being appealed by the drug’s maker, Sprout Pharmaceuticals Inc.


Sprout Pharmaceuticals Alleges Success for New Drug:

This is the second time flibanserin has failed to achieve approval. The first setback occurred in 2010, when the FDA’s Advisory Committee for Reproductive Health Drugs voted 10 to one against recommendation of the drug for approval. The Committee indicated that results obtained by testing were not significantly different from those obtained from placebo, thus failing to compensate for the drug’s side-effects. The latter include dizziness, fatigue, somnolence, nausea and depression.

In June, 2013, Sprout Pharmaceuticals requested approval for flibanserin for a second time, presenting 14 new clinical studies carried out on more than 3,000 new patients (the total number of participants who have taken part in clinical trials for the drug amounts to over 11,000). Cindy Whitehead, President and CEO of Sprout Pharmaceuticals, stated: “In clinical trials, flibanserin has outperformed placebo with statistical significance and, importantly, women treated with flibanserin perceived their improvement to be clinically meaningful”. Additionally, Whitehead claimed that flibanserin’s safety profile is similar to that of other approved drugs and can be ensured through a combination of proper labeling and a responsible product launch.

The Findings of Phase III studies on Flibanserin

The results of a recent phase III clinical trial carried out on over 1,000 patients with generalized acquired Hypoactive Sexual Desire Disorder (characterized by an absence or lack of sexual desire) indicated that women on flibanserin reported that the number of times they enjoyed satisfying sexual events per month rose significantly. The women also evaluated the overall improvement in their condition much more favorably than those in a placebo group, and reported significant reductions in distress associated with low desire, one of the main characteristics of Hypoactive Sexual Desire Disorder.

Reactions from the Medical Community

Many doctors believe that flibanserin would be the first FDA-approved medication for female sexual dysfunction, expressing surprise at its recent rejection, especially considering its efficiency and relative safety. Dr. Sheryl Kingsberg, Chief of Behavioral Medicine at University Hospitals Case Medical Center and Professor in Reproductive Biology and Psychiatry at Case Western Reserve University School of Medicine, noted that in cases where there are no bio-chemical causes for a lack of sexual desire, women, unlike men, have no biopharmaceutical options.  The ability of flibanserin to significantly increase the number of sexual events and too boost the libido, she said, was highly encouraging, specially since the drug also lowered the amount of stress associated with the disorder. Dr. Kingsberg referred to the existence of “a double standard” when it comes to approving drugs with a high risk for men as opposed to a minimal risk for women. The key, she says, is to let women decide for themselves, within the framework of safety. The biggest concern from the medical community is that the rejection of flibanserin may lead to the abandonment of research on this area and the further delay in providing women with efficient, safe medication for their condition.

The Main Causes of Diminished Desire

A woman’s desire for intimacy is based on an intricate network of factors, including physical fitness, emotional stability, beliefs, the state of relationships etc., though many physical conditions (including experiencing pain during sex, suffering from illnesses such as cancer, heart or neurological disease) can also affect one’s level of desire. Alcohol and drugs can likewise hinder one’s sex life, despite the existence of designer drugs and nouvelle drugs like bath salts, which can impart a temporary sense of euphoria and sexual desire, but which hamper performance in the long run. An interesting new study performed on over 900 men at the University of Granada, Spain, found that drug abuse impairs sexual function in men even after rehabilitation. Additionally, hormonal changes which occur in menopause, during and post-pregnancy and while women are breastfeeding, can change the intensity of the libido. Most women and men also find that psychological problems (including stress, anxiety and relationship issues) can greatly affect their sense of confidence and their desire for intimacy.

Does Flibanserin Have a Future?

Scientists at Sprout Pharmaceuticals are confident that their appeal addresses the main reasons stated by the FDA for their rejection and have also presented new findings which may just swing the balance in their favor. Two other drugs which may obtain much-desired approval are Lorexys (currently in Phase II trials) and LibiGel (trials for this drug are currently on standby).