FDA Approves New Drug for Schizophrenia in Adults

A new drug has earned Food and Drug Administration approval to treat adults with the debilitating brain disorder schizophrenia.

Fanapt is made by Patheon Inc. of Ontario, Canada and Vanda Pharmaceuticals Inc. of Rockville, Md. In generic form, the drug is called iloperidone.

Schizophrenia is a chronic and severe brain disorder that affects about one percent of American adults over 18. People with schizophrenia may suffer from delusions, hallucinations such as hearing voices, and abnormal or aggressive expression of emotions. People with schizophrenia may feel scared, withdrawn as a result of the symptoms of the disorder.

Drugs such as Fanapt can ease symptoms of the disorder and allow people with schizophrenia to function better, the FDA said. Fanapt belongs to the class of atypical antipsychotics and carries an increased risk of deadly complications when used to treat non-schizophrenia dementia psychosis in older people. The FDA has not approved Fanapt or other similar antipsychotics for patients with dementia-related psychosis.

In two short-term trials, Fanapt was shown to be effective in reducing the symptoms of schizophrenia, the FDA said.

Common side effects of Fanapt include dizziness, dry mouth, fatigue, nasal congestion, sudden decrease in blood pressure causing light-headedness upon standing (also called orthostatic hypotension), drowsiness, rapid heart rate (also called tachycardia), and weight increase.

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