Alkermes plc — Aristada Initio FDA Review (NDA209830, ORIG 1, 2018)
Alkermes plc · 2018 · FDA Review (openFDA) · company profile →
Report summary
This report summarizes the FDA review of Alkermes' Aristada Initio (aripiprazole lauroxil NanoCrystal Dispersion or AL-NCD), a new formulation designed to simplify the initiation of schizophrenia treatment. The key innovation is reducing the requirement for concurrent oral aripiprazole from 21 days to a single dose. The application leverages pharmacokinetic bridging studies to establish comparable efficacy and safety to the previously approved regimen of Aristada.
Key findings — cited to the page
| Approval date for Aristada (original formulation) | October 5, 2015 | Aristada · United States · p.2 |
| Number of subjects in ALK9072-B101 | 114 subjects | ALK9072-B101 · p.4 |
| Number of subjects in ALK9072-B102 | 161 subjects | ALK9072-B102 · p.4 |
| Number of subjects in ALK9072-B103 | 47 subjects | ALK9072-B103 · p.4 |
| Aripiprazole concentrations considered tolerable and effective | 102 – 435 ng/ml | · p.6 |
| Number of SAEs reported in subjects exposed to AL-NCD | 15 | · p.10 |
| Number of subjects with SAEs exposed to AL-NCD | 6 subjects | · p.10 |
| Total subjects exposed to AL-NCD in development program | 212 subjects | · p.10 |
| SAEs associated with psychiatric disorders SOC | 8 | · p.10 |
| Incidents of suicidal ideation | 1 | · p.10 |
| Recommendation | Approval | · p.2 |
| Application Number | 209830Orig1s000 | Aristada Initio · p.1 |
Source: Alkermes plc ↗ · 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 →