(Adds background, shares, company comment)
Dec 23 (Reuters) - The U.S. Food and Drug Administration has approved Intra-Cellular Therapies Inc's investigational drug to treat schizophrenia, the company said on Monday, sending its shares soaring 40%.
The treatment, Caplyta, is the drug developer's lead candidate that has shown to regulate three neurotransmitter systems serotonin, dopamine and glutamate linked to severe mental illnesses.
The approval comes with a boxed warning, FDA's harshest, saying the drug is not for the treatment of patients with dementia-related psychosis.
Schizophrenia is a chronic mental disorder that causes distortion in thoughts, hallucinations and feelings of fright and paranoia.
"We have a strong commercial team and are fully prepared to launch the drug in the first quarter of 2020," Intra-Cellular Chief Medical Officer Dr. Andrew Satlin said, ahead of the approval, also highlighted the company is in talks with health insurers regarding potential coverage.
The company plans to launch the drug on its own worldwide.
Existing anti-psychotic drugs in the market include Rexulti from Danish drugmaker H. Lundbeck A/S and Japans Otsuka Pharmaceutical Co Ltd, Allergan Plcs Vraylar and Johnson & Johnson's Invega.
In trials, Caplyta did not cause akathisia, a feeling of jitteriness among patients, which is extraordinarily uncomfortable and makes people "jump out of their skin", the company said.
Caplyta is also being developed by Intra-Cellular for other indications including bipolar depression, depressive disorders and agitation in patients with Alzheimers disease. (Reporting by Trisha Roy in Bengaluru; Editing by Maju Samuel and Vinay Dwivedi)