Intra-Cellular drug in higher dose effective in lessening severe schizophrenia symptoms

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Great news comes from Intra-Cellular Therapies Inc., who recently announced that a higher dose of its lead drug called ITI-007 achieved the goals of its late-stage study—effectively reducing the severity of schizophrenia symptoms, Reuters reported.

A biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, Intra-Cellular just concluded the phase 3 clinical trial of ITI-007, wherein it met the primary endpoint and effectively demonstrated antipsychotic efficacy with statistically significant superiority over placebo on its fourth week, which was the study's endpoint.

As early as the first week, the drug had already shown antipsychotic efficacy. ITI-007's 60 mg dose also had a favorable safety and tolerability profile based on its motoric, metabolic, and cardiovascular characteristics, which were similar to placebo. It also had no clinically significant changes in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin or lipids.

According to Nasdaq, Dr. Carol Tamminga, Professor and Chairman, Department of Psychiatry, University of Texas Southwestern Medical School, and the Lou and Ellen McGinley Distinguished Chair in Psychiatric Research said, "ITI-007 demonstrated efficacy in the treatment of patients with schizophrenia. To have achieved efficacy at lower dopamine receptor occupancy levels more commonly associated with clozapine, arguably the most efficacious antipsychotic, while maintaining a placebo-like safety and tolerability profile is a remarkable advance in the development of drugs for schizophrenia."

Dr. Sharon Mates, chair and CEO of Intra-Cellular Therapies, also said that the results of this study support the findings of the phase 2 trial.

"Patients deserve a treatment choice which gives them symptom relief without the associated movement disorders, metabolic disturbances or cardiovascular effects observed with many antipsychotics. We are excited about our progress towards delivering a novel treatment option for patients," she added. 

Reuters reports that schizophrenia is prevalent among over 20 million people worldwide, as per the World Health Organization. Additionally, the CDC reports that persons with schizophrenia are at high risk for suicide. NIMH further reports that about 1 percent of Americans have this chronic, severe, and disabling brain disorder, and symptoms may begin as hallucinations and delusions between the ages of 16 and 30. While there are several factors that may cause schizophrenia, scientists also attribute this illness to genes and environment.

In July, the Huffington Post reported that a study has found a link between smoking and schizophrenia. According to James MacCabe, a psychosis expert who co-led the research at King's College London's Institute of Psychiatry, "While it's always hard to determine the direction of causality, our findings indicate that smoking should be taken seriously as a possible risk factor for developing psychosis. Excess dopamine is the best biological explanation we have for psychotic illnesses. It's possible that nicotine exposure, by increasing the release of dopamine, causes psychosis to develop."

While there is no definite way to prevent schizophrenia, the Mayo Clinic suggests early treatment for those who are experiencing symptoms, to get these under control and avoid complications and improve quality of life following diagnosis.