Alkermes plc — Aristada FDA Review (NDA209830, ORIG 1, 2018)
Alkermes plc · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of Alkermes' Aristada Initio (aripiprazole lauroxil) for schizophrenia focused on pharmacokinetic bridging data to establish comparable efficacy and safety to the approved Aristada regimen. Population pharmacokinetic (popPK) analyses, utilizing data from studies B101, B103, B102, and A105, supported dosing recommendations for various initiation regimens, including simultaneous and staggered starts, and switching from oral aripiprazole. Independent reviewer analysis confirmed the applicant's findings. Two Phase 1 studies (B102 and B103) further investigated ALKS 9072N (aripiprazole lauroxil). Study B102 demonstrated dose proportionality and selected a formulation for further development. Study B103 showed similar pharmacokinetic profiles and bioavailability between deltoid and gluteal administration, suggesting interchangeability of injection sites. No new safety signals were identified in these studies. The review also addressed specific patient populations (e.g., CYP2D6 poor metabolizers) and potential erroneous dosing scenarios.
Key findings — cited to the page
| Number of subjects enrolled | 114 | ALKS 9072N · p.64 |
| Age range of subjects | 18-65 year | ALKS 9072N · p.65 |
| Number of subjects enrolled | 161 | ALKS 9072N · p.78 |
| Age range of subjects | 18-65 year | ALKS 9072N · p.79 |
| Study phase | Phase 1 | ALKS 9072N · p.80 |
| Age range of subjects | 18-65 year | ALKS 9072N · p.83 |
| Relative bioavailability of aripiprazole (deltoid vs gluteal) | near unity | ALKS 9072N · p.88 |
| New safety signals | No new safety signal was identified | ALKS 9072N · p.91 |
| Aripiprazole concentration range considered tolerable and effective | 102 – 435 ng/mL | · p.7 |
| Increase in aripiprazole concentrations for CYP2D6 poor metabolizers | 2-fold | · p.12 |
| Increase in mean aripiprazole concentrations with strong CYP3A4 inhibitor | 1.5-fold | · p.12 |
| Study phase | Phase 1 | ALKS 9072N · p.64 |
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 →