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

 

More Presentations from Dr.Naina Mohamed Pakkir Maideen

Ø 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.

Ø Flibanserin (Addyi) is the first FDA-approved treatments for sexual desire disorders in men or women.

Proposed Mechanism of Action:

Ø Flibanserin activates 5-HT_1A receptors in the prefrontal cortex and improves the balance between excitatory (Dopamine and Norepinephrine) & inhibitory (Serotonin) neurotransmitter systems, at prefrontal cortex leading to regulation of sexual response.

Adverse Drug Reactions:

Ø The most common ADRs noted in the clinical trial participants being treated with Flibanserin, include Dizziness, Somnolence (Sleepiness), Nausea, Fatigue, Insomnia and Dry mouth.

Drug Interactions:

Ø Flibanserin can interact significantly with Alcohol, CYP3A4 Inhibitors, CYP3A4 Inducers, CYP2C19 Inhibitors, Digoxin or other P-gp Substrates and Other CNS Depressants.

Contraindications:

Ø Alcohol consumption

Ø 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.

Ø Hepatic Impairment