Teva: long acting olanzapine TEV’749 or Zyprexa shows success in schizophrenia

1. TEV’749 achieved reductions in schizophrenia symptoms, as measured by differences in the Positive and Negative Syndrome Scale (PANSS) scores, from baseline to 8 weeks of treatment
2. TEV’749 demonstrates safety comparable to other olanzapine formulations, with no reported post-injection delirium/sedation syndrome (PDSS) events

The Latest

The Phase 3 SOLARIS trial assessed the efficacy of Teva’s long-acting antipsychotic TEV’749 in treating adult patients with schizophrenia. Patients were randomized to receive placebo vs. a monthly injection of TEV’749 in low, medium, or high doses. The trial achieved its primary endpoint in all three dosing groups, as patients receiving TEV’749 demonstrated statistically significant reductions in their Positive and Negative Syndrome Scale (PANSS) scores compared to the placebo group. PANSS includes measure of quality of life and social functioning. Baseline PANSS scores were compared to repeat scores after 8 weeks of treatment. The mean score reductions were 9.71 points in the high dosing group, 11.27 points in the medium dosing group, and 9.71 points in the low dose group. Secondary endpoints, including the Clinical Global Impressions scores, showed statistically significant score reductions in the TEV’749 group compared to placebo

Physician’s Perspective

Schizophrenia is a chronic psychiatric disorder characterized by symptoms of psychosis and disrupted cognition and behavior. Although schizophrenia has a variable range of presentations, symptoms can include hallucinations, delusions, disorganized speech, decreased expressiveness, and apathy. Approximately 1% of the world’s population is affected by schizophrenia. Schizophrenia can have severe impacts on social and occupational functioning; thus treatments that can improve quality of life and functioning are very important.

Schizophrenia is commonly treated with a class of medications called antipsychotics. Antipsychotics target specific receptors in the brain to modify neurotransmitter activity. They can be classified as first generation or typical antipsychotics, and second generation or atypical antipsychotics, depending on their receptor targets and mechanism of actions. Antipsychotics should be continued indefinitely to treat schizophrenia, but non-adherence is common due to negative side effects, barriers to accessing treatment, and patient’s lack of insight about their need for treatment. 80% of patients with schizophrenia face a relapse within the first 5 years of treatment, which can lead to psychiatric emergencies, hospitalization, and permanent loss of function.

Molecular Targets

TEV’749 (brand name Zyprexa) is a controlled release, long-acting injection of olanzapine, an atypical antipsychotic medication commonly used to treat schizophrenia. TEV’749 is designed to slowly release olanzapine via SteadyTeq technology, which enables it to be injected once a month. An advantage of long-acting medications like TEV’749 is increased treatment adherence.

Company History

Teva Pharmaceuticals is a multinational biopharmaceutical company responsible for manufacturing many generic and specialty drugs. Teva is known for medications targeting a variety of central nervous system conditions, including Parkinson’s, Huntington’s, and multiple sclerosis. Recently, Teva has worked with MedinCell to utilize SteadyTeq technology in long-acting medications. In addition to TEV’749, Teva is evaluating the use of extended-release risperidone (UZEDY) for the treatment of schizophrenia.

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