The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals’ drug for the treatment of two serious mental health conditions, the company said on Friday.
The drug, branded as Bysanti, is an antipsychotic pill aimed at treating schizophrenia and acute bipolar I disorder.
The approval comes with the FDA’s most serious warning of an increased risk of death in elderly patients with dementia-related psychosis.
Bysanti, chemically known as milsaperidone, belongs to a class of drugs known as atypical antipsychotics that work by blocking dopamine and serotonin receptors in the brain, which help regulate mood, stress, delusions and alertness.
Schizophrenia is a serious mental illness that can cause hallucinations and delusions, while bipolar disorder is marked by dramatic shifts in mood and energy that can disrupt sleep, judgment and daily functioning.
Vanda said it expects to launch the drug in the U.S. in the third quarter of this year.
US FDA approves Vanda’s antipsychotic pill
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