The FDA has approved a new atypical antipsychotic, cariprazine (Vraylar), to treat schizophrenia and bipolar disorder in adult patients, .
The drug was , when the agency asked for more data on adverse events.
Ultimately, a handful of six-week clinical trials totaling more than 2,700 patients showed that the drug reduced symptoms of each condition compared with placebo (there were 1,754 patients in three schizophrenia trials and 1,037 patients in three bipolar disorder trials).
In the schizophrenia trials, the most common adverse events included extrapyramidal symptoms such as tremor, slurred speech, and involuntary muscle movements. The same was true for the bipolar disorder trials, with the addition of akathisia, dyspepsia, vomiting, drowsiness, and restlessness.
Like other antipsychotics, cariprazine will come with a boxed warning about increased risk of death in older people with dementia-related psychosis. No drug is approved to treat that condition, the agency warned.
Cariprazine is a partial agonist of the dopamine D3 and D2 and serotonin 5-HT1A receptors. It's an antagonist of the serotonin 5-HT2B and 5-HT2A receptors, and it also binds to histamine H1 receptors.
It shows lower binding affinity to the serotonin 5-HT2C and α1A- adrenergic receptors and has no appreciable affinity for cholinergic muscarinic receptors, .
Recommended dosing is once a day at 3 to 6 mg for schizophrenia and 1.5 to 6 mg for bipolar disorder.
The drug was discovered and co-developed by Gedeon Richter and is licensed to Actavis, now Allergan, in the U.S. and Canada.