Fanapt™ (iloperidone)
On May 6, 2009 the U.S. Food and Drug Administration (FDA) approved Fanapt™ for the acute treatment of adult patients with schizophrenia. Fanapt™ is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist, belonging in the class of atypical anti-psychotics. The efficacy and safety of Fanapt™ were studied in clinical trials with over 3,000 patients.
For U.S. full prescribing information, including box warnings and safety information, please visit
www.Fanapt.com.
Tasimelteon
Tasimelteon is in development for the treatment of circadian rhythm sleep disorders, to include the transient insomnia of jet lag. Vanda has completed phase 2 and 3 studies that incorporated a 5-hour phase advance of the sleep cycle to simulate, among other things, the circadian misalignment experienced with eastward travel across 5 time zones (similar to flying from Boston to London). In both studies, tasimelteon caused significant improvement in sleep onset and sleep maintenance without evidence of next-day residual effects. Tasimelteon also caused a shift in the intrinsic circadian rhythm as measured by the body’s own production of melatonin. Vanda hopes to submit a marketing application in the U.S. in mid-2011.