With the approval of a new drug in the United States aimed at treating low libido in women, many people in the country begin to question whether this supposed female Viagra is indeed capable of addressing the true causes for this lack of sexual drive
The U.S. Food and Drug Administration (FDA) announced last week that it has approved the use of drug known as flibanserin to treat premenopausal women suffering from the condition called hypoactive sexual desire disorder (HSDD).
The announcement came after almost 20 years since the pill Viagra was given approval by the FDA to treat erectile dysfunction in men.
When Sprout Pharmaceuticals submitted the drug flibanserin to the FDA for approval, the drug maker introduced it as treatment for sexual dysfunction in women, much like those provided to men. Sprout even presented several women during the agency hearings in Maryland in order to attest to the benefits of flibanserin and plead to the FDA for its approval.
Despite concerns about the modest efficacy and health risks and having rejected the drug twice, the FDA decided to approve flibanserin because the agency said women suffering from low libido have what it considers "unmet medical need."
Days after its approval, Valeant, a pharmaceutical company based in Canada, offered to purchase Sprout Pharmaceuticals for $1 billion, stating that it will present flibanserin for approval in Canada and other countries.
While flibanserin is often compared to Viagra, the medication was developed as a form of antidepressant that functions on the patient's brain, while drugs for erectile dysfunction work to stimulate the flow of blood to the penis.
Critics of the use of flibanserin claim that it is a pointless drug for a problem that is more effectively treated through sex therapy, relationship counselling and changes in behavior.
Adriane Fugh-Berman, a physiology and pharmacology professor at Georgetown University, said that the suffering associated with the condition is real.
Fugh-Berman, who is also the director for drug marketing watchdog group known as PharmedOut, argued that the women who testified during the hearings, however, had varying stories regarding low libido, such as one having a one-year-old child, one having six children and one having gone through treatment for breast cancer.
Canadian psychologist Cynthia Graham, from Indiana University's Kinsey Institute, said that many sexual problems are linked to different relationship, contextual and stress issues. She said that she does not believe that these issues could be addressed with medication.
During clinical trials for flibanserin, subjects who were given the drug said that they experienced an average of about 0.5 to one sexual events that they consider satisfying every month compared to those in a placebo group. Those on flibanserin also had only a modest increase in desire and reduction of distress.
Around eight to 13 percent of participants that were given flibanserin said that they experienced an improvement on at least one of the three measures included in the study.
Photo: Pedro Ribeiro Simões | Flickr