On 18th Aug 2015, The U.S. Food and Drug Administration approved Flibanserin (Addyi ) to treat acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

1. FDA APPROVES
FLIBANSERIN (ADDYI)
TO TREAT
SEXUAL DESIRE DISORDER
Dr. P.Naina Mohamed PhD
Pharmacologist

2. Introduction
 On 18th Aug 2015,The U.S. Food and Drug
Administration approved Flibanserin (Addyi ) to
treat acquired, generalized Hypoactive Sexual
Desire Disorder (HSDD) in premenopausal women.
 Flibanserin (Addyi ) is the first FDA-approved
treatments for sexual desire disorders in men or
women.
 The recommended dosage of Flibanserin is 100
mg to be taken once daily at bedtime.

3. Hypoactive Sexual
Desire Disorder (HSDD)
 Hypoactive Sexual Desire Disorder (HSDD) is
defined as a persistent or recurrent deficiency of
sexual fantasies and desire for sexual activity.
 HSDD is believed to be the most common form of
Female Sexual Dysfunction and is associated with
emotional distress and relationship problems.

4. Proposed Mechanism of Action
Flibanserin activates
5-HT1A receptors in
the prefrontal
cortex
Increased Excitatory
(Dopamine and
Norepinephrine) activity
& Decreased Inhibitory
(Serotonin) activity at
prefrontal cortex
Improved balance
between
neurotransmitter
systems
Regulation of sexual
response

5. Adverse Drug Reactions
 Dizziness
 Somnolence (Sleepiness)
 Nausea
 Fatigue
 Insomnia
 Dry mouth

6. Flibanserin & Alcohol
Flibanserin +
Alcohol
Elevated Risk of
Hypotension and
Syncope
Contraindicated

7. Flibanserin &
CYP3A4 Inhibitors
Flibanserin +
CYP3A4
Inhibitors
Inhibition of
metabolism of
Flibanserin
Increased
Flibanserin
concentrations
Hypotension
and SyncopeContraindicated

8. Flibanserin &
CYP3A4 Inducers
Flibanserin +
CYP3A4 Inducers
(Carbamazepine,
Phenobarbital,
Phenytoin,
Rifabutin, Rifampin,
Rifapetine, St. Johns
Wort)
Decreased
Flibanserin
exposure
Reduced
Flibanserin
efficacy

9. Flibanserin &
CYP2C19 Inhibitors
Flibanserin + CYP2C19 Inhibitors
(Proton Pump Inhibitors, Selective
Serotonin Reuptake Inhibitors,
Benzodiazepines, Antifungals,etc.)
Increased Flibanserin
concentrations
Elevated risk of Hypotension,
Syncope and CNS Depression

10. Flibanserin & Digoxin or
Other P-gp Substrates
Digoxin
Toxicitty or
Other P-gp
substrate
toxicity
Increased
concentrations
of P-gp
substrates
Flibanserin + P-
glycoprotein
Substrates
(Digoxin,
Sirolimus, etc.)

11. Flibanserin & Other CNS
Depressants
Flibanserin + Other CNS Depressants
(Diphenhydramine,Opioids,
Hypnotics, Benzodiazepines)
Increased risk of CNS
depression (e.g.,
somnolence)

12. Contraindications
 Alcohol consumption
 Concomitant use of CYP3A4 Inhbitors such as
Macrolide Antibiotics (Erythromycin,
Clarithromycin,Telithromycin, etc.), Azole
Antifungals (Ketoconazole, Fluconazole,
Itraconazole, etc.), Antiretroviral protease inhibitors
(Saquinavir, Ritonavir, Indinavir, Nelfinavir,
Amprenavir, etc.), Ciprofloxacin,Verapamil,
Grapefruit juice, etc.
 Hepatic Impairment

13. References
 http://www.fda.gov/NewsEvents/Newsroom/Press
Announcements/UCM458734.htm?source=govdeli
very&utm_medium=email&utm_source=govdelive
ry
 http://onlinelibrary.wiley.com/doi/10.1111/j.1743-
6109.2010.02032.x/full
 http://jama.jamanetwork.com/article.aspx?articleI
D=2389384
 http://www.futuremedicine.com/doi/abs/10.2217/w
he.10.54

14. References
 http://www.accessdata.fda.gov/drugsatfda_docs/la
bel/2015/022526lbl.pdf
 http://www.sproutpharma.com/wp-
content/uploads/2013/06/jsm12189.pdf
 http://onlinelibrary.wiley.com/doi/10.1111/j.1743-
6109.2011.02626.x/full
 http://www.sciencedirect.com/science/article/pii/S
0014299901014959
 http://www.ncbi.nlm.nih.gov/pubmed/20840530