Fda approves Flibanserin (Addyi ) to treat Hypoactive Sexual Desire Disorder (HSDD)

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 F libanserin ( Addyi ) to treat sexual desire disorder Dr. P.Naina Mohamed PhD Pharmacologist

2. Introduction On 18 th 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

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

6. Flibanserin & Alcohol

7. Flibanserin & CYP3A4 Inhibitors

8. Flibanserin & CYP3A4 Inducers

9. Flibanserin & CYP2C19 Inhibitors

10. Flibanserin & Digoxin or Other P- gp Substrates

11. Flibanserin & Other CNS Depressants

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 , A mprenavir , etc .), Ciprofloxacin, Verapamil, G rapefruit juice, etc. Hepatic Impairment

13. References http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM458734.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery http:// onlinelibrary.wiley.com/doi/10.1111/j.1743-6109.2010.02032.x/full http:// jama.jamanetwork.com/article.aspx?articleID=2389384 http:// www.futuremedicine.com/doi/abs/10.2217/whe.10.54

14. References http:// www.accessdata.fda.gov/drugsatfda_docs/label/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/S0014299901014959 http:// www.ncbi.nlm.nih.gov/pubmed/20840530