FDA Greenlights Amneal’s Risperidone Extended-Release Injectable for Schizophrenia & Bipolar Disorder
WASHINGTON D.C. – September 4, 2025 – The U.S. Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ risperidone extended-release injectable suspension, offering a new long-acting treatment option for individuals with schizophrenia and bipolar I disorder.The medication is indicated for the treatment of schizophrenia and as both an self-reliant treatment and an adjunct therapy alongside lithium or valproate for bipolar I disorder,and will be available in 12.5, 25, 37.5,and 50 mg dose vials.
The approval is based on data from a phase 3 program demonstrating significant improvements in health-related quality of life, physical functioning, and social integration scores among patients treated with the extended-release injectable form of risperidone. The drug exhibited a safety profile consistent with other oral and injectable risperidone formulations.
The phase 3 study included 500 eligible participants, with 92 individuals having completed a prior double-blind study. The participant breakdown from the previous study included 28 (34%) receiving placebo, 31 (33.7%) receiving risperidone ER injectable 90 mg,and 33 (35.9%) receiving risperidone ER injectable 120 mg. An additional 408 new participants with stable schizophrenia were enrolled. Reported side effects included indigestion, sedation, weight increase, pain in an extremity, and dry mouth.
“This approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health,” stated Arash Dabestani, PharmD, senior vice president, Institutional at Amneal, 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.”
The once-monthly subcutaneous injection is designed to achieve clinically relevant therapeutic plasma concentrations on the first day of dosing, eliminating the need for a loading dose or supplemental oral medication. Long-acting injectables are intended to improve medication adherence, a critical factor in managing schizophrenia, as relapse rates are high when patients discontinue treatment.
“This medication, a once-monthly [subcutaneous] extended-release form of risperidone, provides additional treatment options for patients with schizophrenia,” noted Andorn and colleagues, authors of the phase 3 study published in the Journal of Clinical Psychopharmacology in 2019.
Amneal has secured 180-day exclusivity under the FDA Competitive Generic Therapy designation and anticipates launching the product by the end of 2025.
References:
- 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
- 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.
