Addyi (filbanserin) Drug Information

·         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