Vraylar
Publisher: Datamonitor Healthcare
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Drug Overview
Vraylar (cariprazine; Allergan/Gedeon Richter/Recordati) is a novel atypical antipsychotic with partial agonistic activity at the D2 and D3 dopamine receptors, and selectivity for the D3 receptor. Vraylar is also a partial agonist at 5-HT1A receptors and an antagonist at 5-HT2A serotonin receptors. Most atypical antipsychotics have full antagonistic activity at D2 and 5-HT2A receptors, giving cariprazine a unique pharmacology among drugs in the class.
Vraylar was initially developed as a drug for schizophrenia and bipolar disorder, and is now being investigated for the adjunctive treatment of major depressive disorder (MDD) as a line extension. Allergan has completed a single Phase III trial in MDD, which yielded negative data. Vraylar was first approved by the US Food and Drug Administration in September 2015 for the treatment of schizophrenia and bipolar disorder.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Vraylar : Depression
10 Vraylar : Bipolar disorder
23 Vraylar : Schizophrenia
LIST OF FIGURES
18 Figure 1: Vraylar for bipolar disorder – SWOT analysis
19 Figure 2: Datamonitor Healthcare’s drug assessment summary for Vraylar in bipolar disorder
20 Figure 3: Datamonitor Healthcare’s drug assessment summary for Vraylar in bipolar disorder
29 Figure 4: Vraylar for schizophrenia – SWOT analysis
30 Figure 5: Datamonitor Healthcare’s drug assessment summary of Vraylar for schizophrenia
31 Figure 6: Datamonitor Healthcare’s drug assessment summary of Vraylar for schizophrenia
33 Figure 7: Vraylar sales for schizophrenia across the US and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Vraylar drug profile
7 Table 2: Vraylar Phase II and Phase III data in depression
8 Table 3: Vraylar for depression – SWOT analysis
11 Table 4: Vraylar bipolar disorder indication approvals
12 Table 5: Vraylar drug profile
13 Table 6: Overview of key pivotal trial data for Vraylar in bipolar disorder
15 Table 7: Key side effects (≥5%) reported in clinical trials of Vraylar monotherapy for bipolar mania
17 Table 8: Vraylar Phase III trials in bipolar depression
23 Table 9: Vraylar drug profile
25 Table 10: Vraylar pivotal trial data in schizophrenia
29 Table 11: Vraylar other late-phase trial data in schizophrenia
34 Table 12: Vraylar sales for schizophrenia across the US and five major EU markets, by country ($m), 2017–26
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