Latest Injectable Treatments for Schizophrenia
Schizophrenia is a complex and chronic mental health condition that requires consistent medication for effective management. Nonadherence to daily oral antipsychotics is a significant challenge, often leading to symptom relapse and hospitalization. To address this, long-acting injectable (LAI) antipsychotics have been developed to provide a sustained release of medication over weeks or months. Recently, several new LAIs and delivery systems have emerged, expanding the options available to patients and clinicians.
Amneal's Risperidone Extended-Release Injectable Suspension (Approved September 2025)
In September 2025, the U.S. Food and Drug Administration (FDA) approved Amneal Pharmaceuticals' new once-monthly, subcutaneous Risperidone Extended-Release Injectable Suspension for schizophrenia. This injectable uses microsphere technology for a controlled release of risperidone. Key aspects include once-monthly dosing to improve adherence, therapeutic levels from the first day, and subcutaneous administration. Its safety profile is consistent with other risperidone formulations.
Other Notable Recent Injectable Approvals
The field of LAIs has seen other important developments considered new advancements:
- Erzofri (paliperidone palmitate): This once-monthly LAI, approved in July 2024, offers an optimized initial dosing regimen.
- Abilify Asimtufii (aripiprazole): Approved in May 2023, this provides a once-every-two-months injection option for schizophrenia and bipolar I disorder.
- Uzedy (risperidone): This subcutaneous injectable, approved in April 2023, is available as a once-monthly or once-every-two-months dose and showed significant relapse reduction in trials.
Comparison of New and Recent Long-Acting Injectables
| Feature | Amneal Risperidone ER (Late 2025) | Erzofri (paliperidone palmitate, Jul 2024) | Abilify Asimtufii (aripiprazole, May 2023) | Uzedy (risperidone, Apr 2023) |
|---|---|---|---|---|
| Dosing Interval | Once monthly | Once monthly | Once every 2 months | Once every 1 or 2 months |
| Delivery | Subcutaneous | Intramuscular | Intramuscular | Subcutaneous |
| Active Ingredient | Risperidone | Paliperidone palmitate | Aripiprazole | Risperidone |
| Mechanism | Microsphere technology | Prodrug, optimized initial dosing | Extended-release | Microsphere technology |
| Key Benefit | Stable plasma levels from day one | Optimized initial dosing regimen | Infrequent dosing | Reduced relapse rates |
How Injectable Antipsychotics Work
LAIs function by creating a medication depot at the injection site that gradually releases the drug into the bloodstream, ensuring stable concentrations for extended periods. This differs from oral medications like Cobenfy (xanomeline/trospium chloride), approved in September 2024, which use novel oral mechanisms and are not injectables.
Advantages of Long-Acting Injectables
Key benefits of LAIs include improved treatment adherence, reduced relapse rates, better symptom control through stable drug levels, and easier medication monitoring by healthcare providers.
Potential Challenges and Considerations
Considerations for LAIs include potential side effects such as injection site pain, weight gain, and restlessness. Cost and insurance coverage for newer medications can also be significant challenges. Patients also need to commit to regular appointments for injections.
Conclusion
The landscape of schizophrenia treatment is expanding with several new and recently approved long-acting injectable drugs. Amneal's Risperidone Extended-Release Injectable Suspension, approved in September 2025, joins other recent advancements like Erzofri, Abilify Asimtufii, and Uzedy, offering diverse options for patients. These LAIs are crucial in addressing adherence challenges and improving long-term outcomes. Individuals with schizophrenia should consult their healthcare team to find the most suitable treatment plan.
