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Lumateperone (Caplyta) was approved for treating schizophrenia in adults, drugmaker on Monday.

The drug's anticipated approval comes after the and requested additional animal data in July. Lumateperone was originally granted fast-track designation in 2017.

Exactly how the oral, once daily antipsychotic functions remains unknown, although it is thought to have a triple mechanism of action that targets serotonin, dopamine, and glutamate neurotransmitter pathways, according to the pharmaceutical company.

Two trials formed the basis for the approval, showing significant improvement on the Positive and Negative Syndrome Scale (PANSS) with twice the rate of somnolence or sedation (24% vs 10%) and dry mouth (6% vs 2%) compared to placebo, Intra-Cellular Therapies reported.

Notably, metabolic changes like weight gain, fasting glucose, triglycerides, and total cholesterol remained similar between active and placebo arms in these trials, they added.

Lumateperone was approved with a about increased risk of death for elderly patients with dementia-related psychosis. The label also notes increased risk for cerebrovascular events in this population.

Other potential adverse reactions associated with antipsychotics include neuroleptic malignant syndrome, tardive dyskinesia, falls, seizures, cognitive or motor impairment, dysphagia, and body temperature dysregulation. The drug also carries a risk for orthostatic hypotension and syncope as well as leukopenia, neutropenia, and agranulocytosis.

Clinicians should avoid concomitant use of lumateperone and CYP3A4 inducers including phenobarbital, or moderate to strong CYP3A4 inhibitors such as telithromycin (Ketek), the manufacturer noted.

The drug, which is also in development for the treatment of bipolar depression, dementia, and depression, is expected to go on the market in the upcoming year, Intra-Cellular Therapies said. Last summer, though, the in a phase III trial in patients with bipolar depression.

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