Extended‑release olanzapine may improve adherence to treatments for schizophrenia

Teva has submitted a new drug application (NDA) to the FDA for a once‑monthly, extended‑release injectable formulation of olanzapine for adults with schizophrenia. If approved, this long‑acting injectable (LAI) could expand treatment options and address adherence challenges that remain a central issue in schizophrenia care.

Teva Pharmaceuticals announced on Dec. 9 that it has filed an NDA with the FDA for olanzapine extended‑release injectable suspension (TEV‑749). Supported by phase 3 SOLARIS trial data, this therapy uses SteadyTeq™ copolymer technology for monthly subcutaneous olanzapine delivery in adults aged 18 to 64, aiming for steady drug levels and lower relapse risk. Olanzapine is sold under the brand name Zyprexa but is available as a generic.

The SOLARIS trial was a phase 3 randomized, double-blind, placebo-controlled study that took place over the course of 56 weeks. Adults aged 18 to 64 years with schizophrenia received different doses of olanzapine LAI once a month or placebo in a 1:1:1:1 ratio. TEV‑749 met its efficacy and safety endpoints. It showed significant improvements in schizophrenia symptoms, a safety profile consistent with oral olanzapine, and importantly, no cases of post‑injection delirium/sedation syndrome, a major limitation of the older Zyprexa Relprevv LAI.

Olanzapine is a well‑established second‑generation antipsychotic widely used in oral form for schizophrenia and bipolar disorder. A long‑acting injectable version with a better safety profile could extend its utility by improving adherence, a critical factor in long‑term outcomes. Teva already markets Uzedy, a risperidone‑based LAI approved in 2023, and sees olanzapine LAI as a complementary product that could broaden its schizophrenia franchise.

Schizophrenia is a persistent psychiatric condition characterized by frequent nonadherence to oral medications. The pattern of nonadherence often results in relapses, increased rates of hospitalization, and greater healthcare expenditures. LAIs are formulated to sustain therapeutic drug concentrations over extended periods, thereby minimizing the necessity for daily oral dosing and enabling clinicians to more effectively monitor patient adherence.

For patients, LAIs can mean fewer relapses, more stable functioning, and reduced risk of emergency interventions. For payers and providers, they can translate into lower hospitalization rates and improved cost‑effectiveness. Olanzapine LAI, if approved by the FDA, would add another option to the growing portfolio of extended‑release antipsychotics, particularly valuable given olanzapine’s established efficacy profile.

Several long‑acting injectable antipsychotics are already FDA‑approved for schizophrenia, including Uzedy (risperidone), also made by Teva; Risperdal Consta (risperidone); Invega Sustenna (paliperidone palmitate); Invega Trinza; Invega Hafyera; Erzofri (paliperidone palmitate);and Abilify Maintena (aripiprazole).

This schizophrenia treatment landscape shows that there has been a big move toward longer dose intervals, which gives patients and clinicians more options. Every medication has its own pharmacological effects, but they all have the same goal: to help and enhance the likelihood that those with schizophrenia will stick with their treatment and lower their chance of relapse.

Teva's olanzapine LAI will be another tool in the treatment of schizophrenia since it combines the known effectiveness of olanzapine with the benefits of LAI for keeping patients on track. If the FDA approves the NDA, it will join a growing but competitive market for LAIs, giving doctors another way to customize treatment for each patient. For payers, the promise is lower costs connected to relapses and better long-term results.

As treatment for schizophrenia changes, LAIs are becoming increasingly important as maintenance therapy. Teva's pursuit of an FDA approval of olanzapine LAI is part of an ongoing attempt to improve adherence and stability for people with schizophrenia.