AbbVie Inc. — Vraylar FDA Review (NDA204370, SUPPL 6, 2019)
AbbVie Inc. · 2019 · FDA Review (openFDA) · company profile →
Report summary
VRAYLAR (cariprazine) received FDA approval on May 24, 2019, for treating depressive episodes associated with bipolar I disorder in adults, expanding its existing indications for schizophrenia and manic/mixed episodes. The approval followed a Prior Approval Supplement submission by Allergan Sales, LLC, supported by Phase 3 studies (RGH-MD-53, -54, -56) demonstrating VRAYLAR's efficacy. Specifically, the 1.5 mg/day dose consistently showed statistical significance in improving depressive symptoms (MADRS, CGI-S), while the 3 mg/day dose's effectiveness was less consistent. The 0.75 mg dose lacked efficacy. Safety information highlights metabolic changes, extrapyramidal symptoms (akathisia), and other adverse reactions like somnolence. Warnings include increased mortality in elderly dementia patients and suicidal thoughts in pediatric/young adult patients. The safety profile for lower doses (1.5 mg, 3 mg) was considered better than higher doses, with restlessness and akathisia being common. The report also details VRAYLAR's mechanism of action, pharmacokinetic profile, and efficacy in schizophrenia trials.
Key findings — cited to the page
| Indication | Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults | VRAYLAR · U.S. · p.10 |
| Somnolence incidence | 3 % | · p.95 |
| Study initiation date for RGH-MD-53 | 31 March 2016 | RGH-MD-53 · p.145 |
| Number of study centers for Study RGH-MD-53 | 89 centers | RGH-MD-53 · p.144 |
| New Indication | treatment of depressive episodes associated with bipolar I disorder (bipolar depression) | Vraylar · U.S. · p.4 |
| Pediatric study requirement waiver | ages 0 to 9 years | U.S. · p.5 |
| Pediatric study deferral | ages 10 to 17 years | U.S. · p.5 |
| Deferred pediatric study completion | 01/2024 | 3619-1 Deferred pediatric study under PREA (ages 10 to 17) with a diagnosis of acute bipolar depression associated with bipolar I disorder. · p.6 |
| Boxed Warning | Increased Mortality in Elderly Patients with Dementia-Related Psychosis | VRAYLAR · U.S. · p.10 |
| Boxed Warning | Suicidal Thoughts and Behaviors | VRAYLAR · U.S. · p.10 |
| Indication | Treatment of schizophrenia in adults | VRAYLAR · U.S. · p.10 |
| Indication | Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults | VRAYLAR · U.S. · p.10 |
Source: AbbVie 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 →