The Little Pink Pill Approved

On Tuesday August 18th the FDA finally approved the highly controversial Addyi (flibanserin), more commonly referred to as "the little pink pill," after two previous denials. The medication, being touted as the female Viagra, is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is defined as "low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of another drug substance."

While Addyi is a 5HT 1A agonist and 5HT 2A antagonist, its exact mechanism in relieving the effects of HSDD is unknown. The most common side effects of this medication are dizziness, fatigue/somnolence, nausea, insomnia and dry mouth. It should be dosed at bedtime to reduce the risks of falls or adverse events from CNS depression, hypotension and syncope. Addyi is certainly not without risk; the approval comes with a Black Box Warning for a risk of severe hypotension and syncope when used in combination with alcohol, strong CYP3A4 inhibitors (clarithromycin, erythromycin, ketoconazole, itraconazole, diltiazem, grapefruit juice, etc), or impaired liver function.

Trials for the approval of this medication included three 24-week randomized, double-blind, placebo control trials with an average participant age of 36 years. Women reported the number of "satisfying sexual events," sexual desire (scale of 1.2 to 6), and distress related to low sexual desire (scale of 0 to 4). The number of satisfying sexual events increased from 0.5 to 1 additional event compared to placebo  per month. The sexual desire score increased by 0.3 to 0.4, and the distress score related to sexual desire decreased by 0.3 to 0.4 over placebo. Patients may have difficulties obtaining access to Addyi, as it can only be dispensed by REMS-certified physicians and pharmacies. It is yet to be determined if the modest benefits will outweigh the obvious risks of this medication.

SOURCE:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm