A drug to treat schizophrenia shows promising results in final tests

Modern life can lead to higher levels of stress and anxiety, which is reflected in the increase in the incidence of mental disorders, but also an intensification of symptoms. Schizophrenia is a major mental disorder, which includes a series of conditions in the class of psychoses (disorders that alter thinking and perception), and is characterized by a cognitive deficit and a significant functional decline. As it is a spectrum of symptoms, and not a condition in its own right, the differential diagnosis is particularly important, in order to distinguish between schizophrenia and other disorders, such as affective disorders or those triggered by the use of hallucinogenic substances .

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects the way a person thinks, feels and acts.

Patients present with a range of symptoms, which may include delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability.

About 1 percent of the world’s population will develop schizophrenia in their lifetime, according to estimates, and 3.5 million Americans are currently diagnosed with the condition.

An experimental schizophrenia drug developed by Israeli pharmaceutical company Teva Pharmaceuticals and its French partner Medincell, a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in numerous therapeutic areas, has met its primary goal of to reduce the severity of symptoms in an advanced-stage study, the two companies announced Wednesday.

The drug, called TEV-‘749 (olanzapine), met the primary endpoint of the 675-patient study in efficacy tests, which was to reduce the severity of symptoms compared to a placebo when measured on a widely used scale known as the Positive and Negative Syndrome Scale (PANSS), according to a statement from the Israeli pharmaceutical manufacturer.

The companies hope that the drug, which is the most prescribed second-generation generic antipsychotic for schizophrenia in the United States, olanzapine, can be used as a once-a-month subcutaneous injection for patients with the chronic mental disorder.

The drug uses a proprietary technology developed by Medincell to provide a controlled and constant release of olanzapine, which is commonly used as a treatment for schizophrenia but is linked to the risk of Post-Injection Sedation/Delirium Syndrome (PDSS) – a rare syndrome that is specific to the long-acting injectable formulation of olanzapine, olanzapine pamoate.

The companies stated that there were no cases of PDSS reported in the study.

PDSS causes a sudden and unexpected onset of delirium or sedation within the first few hours of treatment and is associated with long-acting injections into a muscle.

Other treatments for this disease include Fanapt (iloperidone), from the manufacturer Vanda Pharmaceuticals, and other generic drugs such as quetiapine and aripiprazole.

US pharmaceutical group Bristol-Myers Squibb (BMS) is also developing a schizophrenia drug called KarXT, and a decision from the US FDA is expected in September.

Although schizophrenia can occur at any time in life, the average age of onset tends to be in the late teens to early 20s for men and the late 20s to early 30s for women.

The disorder affects about 3.5 million people in the United States, and its symptoms include delusions, hallucinations, disorganized speech, problems with thinking, and lack of motivation.

Often, patients are not aware of their disease and its consequences, which contributes to non-compliance with treatment.