Sprout announced that that Addyi (flibanserin) tablets are now available for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi was approved by the Food and Drug Administration (FDA) in August 2015.
Flibanserin is a once-daily, non-hormonal drug that is the first post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist available for this condition. Flibanserin may exert its effect by restoring prefrontal cortex control over the brain’s motivation/rewards structures enabling sexual desire to manifest. Specifically, it increases dopamine and norepinephrine while transiently decreasing serotonin in the brain’s prefrontal cortex, which may be accomplished by reduced glutamate transmission.
Addyi was approved with a Boxed Warning stating the increased risk of severe hypotension and syncope when used with alcohol. Also, severe hypotension and syncope occurs when used with concomitant moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment.
Addyi will be available through healthcare prescribers and pharmacies that are enrolled in the Addyi Risk Evaluation and Mitigation Strategy (REMS) program. It is supplied as 100mg strength tablets in 30-count bottles.
For more information call (844) 746-5745 or visit Addyi.com.