Teva unveiled the results of the clinical trial in the third and crucial phase of the new version of the drug Risperidone

This weekend, Teva unveiled the results of the clinical trial in the third and crucial phase of the new version of the drug Risperidone that it is developing, and is intended for the treatment of schizophrenia patients. The drug has been able to bring about an improvement in dealing with the disease.
Teva is developing a subcutaneous injection with a delayed release of the drug, which was developed with the help of technology from MedinCell, and will be entitled to royalties from its sales. The trial included 544 patients divided into three equal groups. The first group received the injection developed by Teva once a month, the second group received the injection once every two months and the third group received a placebo (placebo). The results of the third clinical trial, unveiled at the annual Psych Congress in San Antonio, Texas, showed that the new version of the drug extended the time to recurrence of disease symptoms 3.5 and 5.0 times, relative to the placebo group.
In addition, the new version of Risperidone (TV-46000 / MDC-IRM) reduces the percentage of patients who experience symptoms in the 24th week of treatment (7% and 11% in the treatment groups compared to 28% in the placebo group with high statistical significance), and a significant increase in the percentage of patients Who manage to maintain stability throughout the treatment (87% and 80% in the treatment groups compared to 61% in the placebo group). The safety profile of the new version matches the safety profile of the other versions of Rasperidone.
Teva has submitted an application to the US Food and Drug Administration, FDA, for approval of the drug. The FDA began its examination at the end of August 2021.
Schizophrenia is a chronic, progressive and limiting mental disorder that affects the way you think, feel and behave. Patients experience symptoms that include delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability. 20 million people suffer from schizophrenia, and 70% of them do not receive appropriate treatment.
Dr. Eran Harari, senior vice president of source drugs at Global R&D in Nature, noted that there is a high recurrence rate of the disease symptoms among people who suffer from schizophrenia and do not adhere to medication, ranging from 50% to 92%. Harari noted that patients with schizophrenia Characterized by a low response rate to medication due to a variety of reasons including constant difficulty in taking daily treatment, partial understanding of the importance of treatment as well as fear of side effects such as a feeling of stiffness and drowsiness.
He cited studies showing that 75% of patients on medication stopped taking the drug within two years of starting treatment, and as a result are at increased risk for another seizure that causes psychotic deterioration and cognitive impairment. According to him, 5% of schizophrenia patients commit suicide and their life expectancy is 10-15 years shorter than the average. Attempts to treat the low response rate to oral drugs have led to the development of drugs with sustained action, which have led to an improvement in the condition of patients. However, they are given by injection into a painful, uncomfortable intramuscular muscle.