Alkermes plc — Aristada FDA Review (NDA209830, ORIG 1, 2018)
Alkermes plc · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA clinical review recommends approval for Alkermes' Aristada Initio (aripiprazole lauroxil) for schizophrenia, citing a favorable benefit-risk profile. This new formulation simplifies treatment initiation by providing comparable drug exposure to the existing oral aripiprazole strategy, addressing compliance issues. The NDA is supported by pharmacokinetic studies (B101, B102, B103) that established optimal dosing and compared initiation regimens, demonstrating therapeutic concentrations. Safety analyses from these Phase 1 studies revealed no new safety signals compared to previous aripiprazole lauroxil data, covering adverse events, clinical tests, and injection site reactions. The report also addresses regulatory background, manufacturing, and post-market safety concerns for Aristada, noting no new REMS or post-marketing commitments for Aristada Initio.
Key findings — cited to the page
| CGI-S score for inclusion | 3 | Study B102 · p.32 |
| QTcF exclusion criterion for men | 450 msec | Study B102 · p.33 |
| Aristada Initio single dose strength | 675 mg | Aristada Initio · p.11 |
| Age range for inclusion | 18 and 65 years of age | Study B102 · p.32 |
| BMI range for inclusion | 18.0 and 40.0 kg/m2 | Study B102 · p.32 |
| Oral aripiprazole single dose strength | 30 mg | · p.11 |
| Percentage of male subjects | 73.3 % | Study B102 · p.38 |
| Reference Drug (oral aripiprazole) NDA | 021436 | Abilify · p.11 |
| Supplement 002 Approval Date | June 5, 2017 | · p.10 |
| Additional Dosing Schedule (Aristada) | 1064 mg IM every eight weeks | Aristada · p.10 |
| Oral aripiprazole duration for initiation | 3 weeks | · p.10 |
| QTcF exclusion criterion for women | 470 msec | Study B102 · p.33 |
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 →