FDA Approves Risperidone Extended-Release Injectable Suspension

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The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' risperidone extended-release (ER) injectable suspension, an atypical antipsychotic for treatment of schizophrenia and maintenance of bipolar 1 disorder.¹

The approval was based on phase 3 trial results, which included a double-blind placebo-controlled trial, along with a 52-week open-label study of the medication. Over the 12 months of exposure in the open-label study, mean Positive and Negative Syndrome Scale scores improved in patients continuing from the first double-blind study, and new participants scores remained stable.² With regards to the Mean Clinical Global Impression assessment, severity scores remained stable among all participants. The most commonly reported adverse effects for this medication were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increased, pain in extremity, and dry mouth. A total of 500 participants were eligible for phase 3 participation; 92 individuals had completed the previous double-blind study, 34% had received placebo (n = 28), 33.7% had received risperidone ER injectable 90 mg (n = 31), 35.9% had received risperidone ER injectable 120 mg (n = 33), and 408 were new participants with stable schizophrenia.

Participants treated with this form of risperidone also showed significant improvements in health-related quality of life, physical functioning, and social integration scores.² The drug had a similar safety profile to oral and other injectable forms of risperidone.² This medication, “a once-monthly [subcutaneous] extended-release form of risperidone, provides additional treatment options for patients with schizophrenia,” said Andorn and colleagues, authors of the phase 3 study.²

This injectable form of risperidone is currently indicated for treatment of schizophrenia and as an independent or adjunct treatment with lithium or valproate for bipolar disorder I. It has been approved for 12.5, 25, 37.5, and 50 mg dose vials. It is designed to give clinically relevant therapeutic plasma concentrations on the first day of dosing, with no need for a loading dose or supplemental oral dosing.²

Schizophrenia often requires lifelong treatment, and relapse rates are high when patients discontinue medication. Long-acting injectables like risperidone extended-release injection can improve adherence compared with daily oral medications. By reducing the need to take a pill every day, LAIs help minimize missed doses, which is a common contributor to relapse and hospitalization for patients.

“This approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health,” said Arash Dabestani, PharmD, senior vice president, Institutional, in a press release. “Risperidone extended-release injectable suspension requires advanced capabilities—such as microsphere formulation and cold-chain manufacturing—that underscore Amneal’s leadership in developing and producing complex medicines. This milestone reflects our strong R&D and manufacturing expertise and lays the foundation for future microsphere-based long-acting injectables.”¹

The product currently has a 180-day exclusivity under the FDA Competitive Generic Therapy designation. The drug is expected to launch in the end of 2025.

References

1. Amneal receives U.S. FDA approval for risperidone extended-release injectable suspension. Press release. September 4, 2025. Accessed September 8, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S--FDA-Approval-for-Risperidone-Extended-Release-Injectable-Suspension/default.aspx

2. Andorn A, Graham J, Csernansky J, et al. Monthly extended-release risperidone (RBP-7000) in the treatment of schizophrenia: results from the phase 3 program. J Clin Psychopharmacol. 2019;39(5):428-433.