On March 10, 2015 we first reported that after two failed applications, Sprout Pharmaceuticals had applied for a third time seeking FDA approval of the female libido pill Flibanserin (See http://www.liattorney.com/scales-of-justice/fda-considering-approval-of-female-libido-pill). It appears that three times is the charm, as the FDA has now approved Flibanserin as the first drug to combat generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The most common side effects of the drug include dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth. In addition, the drug can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These additional risks are increased and more severe when patients drink alcohol or take certain other medicines. Accordingly, the use of alcohol is contraindicated and health care professionals must assess the likelihood of the patient's reliability in abstaining from alcohol before prescribing the drug.
In order to further safeguard women taking Flibanserin, doctors and pharmacists alike are required to become certified in risk evaluation and mitigations strategy (REMS). The FDA has also required a box warning highlighting the severe risks associated with the medication.
Test trials of the drug appear to have had lackluster results. The double blind study found that Flibanserin, as compared to the placebo group, increased the amount of satisfying sexual events by .5 to 1.0 event per month. In addition there was a 10 percent increase in reported "meaningful improvement" over the placebo group. Although the FDA previously denied approval on the basis that the benefits did not outweigh the detriments, it has now approved this third application with limited explanation as to justification.
Ultimately, the risk versus reward analysis will be up to the patient, as this first "female Viagra" pill is likely to generate a world wide windfall of profit. Case and point is that subsequent to receiving FDA approval, Sprout Pharmaceuticals announced that they are being acquired by Valeant Pharmaceuticals International for One Billion Dollars. Hopefully the end result for Flibanserin will be true relief for women with HSDD and not the focus of a major class action lawsuit.
Long Island Lawyer
Paul A. Lauto, Esq.