SHANDONG LUYE — Rykindo FDA Review (NDA212849, ORIG 1, 2023)
SHANDONG LUYE · 2023 · FDA Review (openFDA) · company profile →
Report summary
The FDA reviewed Rykindo (risperidone extended-release injectable suspension) for schizophrenia and bipolar I disorder. Initial concerns arose from unexplained, significant drug concentration spikes (dose dumping) in a US clinical study, leading to two Complete Response letters. The applicant attributed these spikes to cocaine's CYP2D6 inhibition, but the Agency rejected this, noting the observed increases far exceeded those caused by known inhibitors. While animal studies showed expected risperidone-related effects and clinical studies demonstrated bioequivalence to Risperdal Consta, the persistent, unexplained concentration spikes remained a major safety concern. Subsequent data from EU and China studies, however, did not show evidence of dose dumping, leading to a favorable benefit-risk assessment and a recommendation for approval.
Key findings — cited to the page
| Assessment measurement irregularity deviations (LD group) | 2 (3.7%) | LY03004/CT-USA-102 · p.166 |
| Assessment measurement irregularity deviations (LY03004 group) | 2 (3.7%) | LY03004/CT-USA-102 · p.166 |
| Assessment measurement irregularity deviations (Total) | 4 (3.7%) | LY03004/CT-USA-102 · p.166 |
| Irritability adverse event rate | 4.2% | LY03004 · p.195 |
| ALT increased (AE leading to discontinuation) on LY03004 | 2 | LY03004/CT-EUR-101 · p.79 |
| Application Type | NDA Resubmission | Rykindo (risperidone extended-release injectable suspension) · p.2 |
| Complete Response Letter Issue Date | February 18, 2022 | LY03004 · p.11 |
| Review Completion Date | January 13, 2023 | Rykindo (risperidone extended-release injectable suspension) · p.2 |
| regulatory action | CR | LY03004 · p.66 |
| Recommended Regulatory Action | Approval | Rykindo (risperidone extended-release injectable suspension) · p.2 |
| Recommended Indication | Treatment of schizophrenia in adults; As monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults | Rykindo (risperidone extended-release injectable suspension) · p.2 |
| PDUFA Goal Date | January 14, 2023 | Rykindo (risperidone extended-release injectable suspension) · p.2 |
Source: SHANDONG LUYE ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →