· Background
o HSDD 7.7 to 14% of premenopausal women in the US or 5.5 to 8.6 million individuals
o developed by Sprout pharmaceuticals
o approved by FDA on June 4, 2015
· Indication
o hypoactive sexual desire disorder (HSDD)
· Adverse effects
o fainting, nausea, dizziness, sleepiness, low blood pressure
· Mechanism
o mechanism is unknown
o mixed agonist/antagonist effect on postsynaptic serotonergic receptors
o 5HT1A agonist and 5HT2A antagonist
· Concerns
o avoid with alcohol due to concerns about central nervous system depression, hypotension, syncope
o avoid in pregnant women
o avoid with strong or moderate CYP3A4 inhibitors
o prior to HSDD, it was considered for antidepressant indication and though all antidepressants have a black box warning for suicides, there is no sign of increase risk with filbanserin
· Pharmacokinetics
o peak levels reached in 45 to 60 minutes of administration
o peak levels are delayed by 1 to 3 hours with meal
o terminal elimination half-life is 12 hours
o taking with high fat high calorie meal increases exposure 50%
o administration with CYP3A4 inhibitors (ketoconazole, fluconazole) increases filbanserin 4.5 and 7 times, respectively
o hormonal contraceptives are weak inhibitors of CYP3A4, but increase filbanserin 40%
Source:
Pharmacy Times. What to Know About “Female Viagra” Backed by FDA Panel. http://www.pharmacytimes.com/news/what-to-know-about-female-viagra-backed-by-fda-panel#sthash.UW4UXYXR.dpuf
Pharmacy Times. What to Know About “Female Viagra” Backed by FDA Panel. http://www.pharmacytimes.com/news/what-to-know-about-female-viagra-backed-by-fda-panel#sthash.UW4UXYXR.dpuf
