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Iloperidone Launched in the United States
Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self. It often includes psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late adolescence or early adulthood and affects 2.4 million Americans or 1.1% of the adult population.
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.
Source: Vanda Pharmaceuticals