Novel Drug For Schizophrenia To Hit The Market Following FDA Approval

The Food and Drug Administration (FDA) has given its official stamp of approval to a drug that could potentially revolutionize the treatment of schizophrenia. A new pharmaceutical company called Intra-Cellular Therapies Inc., specializing in the development of novel therapies to treat central nervous system disorders, was granted the approval recently, Med Page Today reported Monday.

Caplyta (Lumateperone) is an oral medication meant to be taken at 42 mg once a day. It is slated to be introduced in the pharmaceutical market by the first quarter of 2020. The company has decided to carry out its own marketing across the globe and plan to reveal the price of the drug immediately prior to its commercial launch, Reuters reported.

The psychiatric illness affects 1 percent of the global population, with the common symptoms such as hallucinations, incoherent speech, delusions, not displaying facial expressions and an inability to concentrate. Caplyta is aimed at three important neurotransmitter pathways, namely serotonin, dopamine and glutamate, to improve these symptoms in 2.4 percent of the population with schizophrenia in the U.S.

To measure the efficacy among participants in two trials, the Positive and Negative Syndrome Scale (PANSS) was used by the team, which is a medical scale used to evaluate the symptoms of schizophrenia. Side effects were compared to placebo groups. Sedation was found to be present in 24 percent of the people taking the medication for trial compared to the 10 percent of the participants taking placebo.

Dry mouths were observed in 6 percent of the group taking the drug and in 2 percent of the group on placebo substances. Rates of glucose, total cholesterol and weight gain were the same in both groups during the trial. 

“We believe CAPLYTA provides healthcare providers a new, safe and effective treatment option to help the millions of adult patients with schizophrenia. This approval represents the culmination of years of scientific research. We are especially grateful to the patients, their caregivers, and the healthcare professionals who have contributed to the development of Caplyta,” Dr. Sharon Mates, CEO of Intra-Cellular Therapies Inc., said, as quoted by the news release on the company website. 

“Schizophrenia is a complex disease that severely impacts patients and their families,” Jeffrey A. Lieberman, chairman of psychiatry at Columbia University, College of Physicians and Surgeons, said.  

“Effective treatment provided in a timely fashion can be game-changing for people living with schizophrenia. The efficacy and safety profile of Caplyta approved by the FDA, offers healthcare providers an important new option for treating people living with schizophrenia,” Lieberman added. Lumateperone is also being concurrently developed to treat neuropsychiatric disorders, which the company is planning to make commercially available next year. 

A lot of people cannot overcome schizophrenia since they tend to discontinue the medication due to its side effects. Intra-Cellular Therapies is being transparent about all its potential medical consequences. 

A boxed warning on the label reads: “Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Caplyta is not approved for the treatment of patients with dementia-related psychosis.”

More of the adverse reactions listed by the news release include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, leukopenia, neutropenia and agranulocytosis (including fatal cases).

The other side effects are orthostatic hypotension and syncope, falls, seizures, potential for cognitive and motor impairment, body temperature dysregulation and dysphagia. 

Schizophrenia Drug Plaster models of heads are seen at an exhibition in London March 27, 2012. REUTERS/CHRIS HELGREN