ACADIA Pharmaceuticals Inc. — Nuplazid FDA Review (NDA210793, ORIG 1, 2018)
ACADIA Pharmaceuticals Inc. · 2018 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of ACADIA Pharmaceuticals' Nuplazid (pimavanserin) recommends approval for both the new 34-mg capsule and a 10-mg tablet formulation. The 34-mg capsule was found to be bioequivalent to two 17-mg tablets, with no new safety concerns regarding impurities or degradants. The 10-mg tablet offers improved dosage adjustment for patients on strong CYP3A4 inhibitors. Study ACP-103-043 confirmed the bioequivalence and general safety of the 17-mg tablets and 34-mg capsules, reporting no deaths or serious adverse events. The FDA is currently evaluating post-marketing reports of deaths.
Key findings — cited to the page
| NDA 210793 submission date | August 31, 2017 | Nuplazid (pimavanserin) · p.9 |
| NDA 207318 Supplement S-003 submission date | October 27, 2017 | Nuplazid (pimavanserin) · p.9 |
| Pharmacologic Class | Atypical antipsychotic (Serotonin receptor 2A (5-HT2A) inverse agonist) | Pimavanserin · p.51 |
| Application Number | 207318/s-003 | Nuplazid (pimavanserin) · p.2 |
| PDUFA Goal Date | June 30, 2018 | · p.2 |
| Recommended dose for Nuplazid | 34 mg | Nuplazid (pimavanserin) · p.9 |
| Recommended dose for Nuplazid with strong CYP3A4 inhibitors | 10 mg | Nuplazid (pimavanserin) · p.12 |
| Review Completion Date | May 23, 2018 | · p.2 |
| Recommended Regulatory Action | Approval for both NDA 210793 and NDA 207318/S-003 | Nuplazid (pimavanserin) · p.2 |
| Application Number | 210793 | Nuplazid (pimavanserin) · p.2 |
| Approval date for Nuplazid | April 29, 2016 | Nuplazid (pimavanserin) · p.9 |
| Application number | 210793 | Nuplazid (pimavanserin) · p.48 |
Source: ACADIA Pharmaceuticals Inc. ↗ · 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 →