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Fanapt™ (iloperidone)
Fanapt belongs to a class of medications for schizophrenia known as atypical antipsychotics. The term "atypical" refers to the different mechanisms of action of second-generation antipsychotics.
The FDA approval of Fanapt was supported by two placebo- and active-controlled short-term (4- and 6-week) trials and safety data derived from more than 2,000 patients. Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of 12 mg to 24 mg per day -- which is the recommended daily target dose range. Titration to the target dose of 12 mg per day can be achieved in 4 days.
For U.S. full prescribing information, including box warnings and safety information, please
click here.
Tasimelteon
Tasimelteon is an oral compound in development for sleep and mood disorders, including Circadian Rhythm Sleep Disorders (CRSD). Examples of CRSD include transient disorders such as jet lag and chronic disorders such as shift work sleep disorder and Non-24-Hour Sleep/Wake Disorder. Tasimelteon binds selectively to the brain's melatonin receptors, which govern the body's natural sleep/wake cycle. Compounds that bind selectively to these receptors are thought to be able to help treat sleep disorders, and additionally are believed to offer potential benefits in mood disorders.
Tasimelteon has been shown to improve sleep parameters in prior clinical studies that simulated a desynchronization of the circadian clock. In two such studies, tasimelteon caused significant improvement in sleep onset and sleep maintenance without evidence of next-day residual effects. On January 19, 2010, the FDA granted orphan drug designation status for tasimelteon in Non-24-Hour Sleep/Wake Disorder in blind individuals without light perception.
For Clinical Trial Information, click here.
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