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. Fanapt™ has proven efficacy for schizophrenia in adults. The safety and tolerability of Fanapt™ has been established in more than 3,000 patients.
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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.