Allergan plc has announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the US in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder. Allergan plc is headquartered in Dublin, Ireland.
Dosage/administration: For schizophrenia, Vraylar should be administered once daily, with or without food. The starting dose is 1.5 mg/day; recommended dose is 1.5 mg to 6 mg/day.
Adverse effects: The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) for patients taking Vraylar for schizophrenia were extrapyramidal symptoms and akathisia.
Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia. [news release] Dublin, Ireland: Allergan plc. November 13, 2017. https://www.allergan.com/News/News/Thomson-Reuters/Allergan-Receives-FDA-Approval-For-Use-of-VRAYLAR. Accessed November 14, 2017.
This Week's Must Reads
Early Intervention Backed for Early-phase Psychosis, JAMA Psychiatry; ePub 2018 May 2; Correll, et al
Cultural Disparities Among Social Support Seekers, Psychiatry Res; ePub 2018 May 6; Herbert, et al
Caffeine May Promote Early Use of Other Substances, Addiction; ePub 2018 Apr 30; Krisjansson, et al
Relationship Between Schizotypal Traits, Hoarding , J Affect Disord; ePub 2018 May 4; Weintraub, et al
Defining Sexual Wellness in Mid- and Later Life, J Sex Res; ePub 2018 Apr 18; Syme, Cohn, et al
Must Reads in FDA Actions
FDA Approves Injectable Form of Buprenorphine, FDA news release; 2017 Nov 30
FDA Grants Approval for Opioid Withdrawal Device, FDA news release; 2017 Nov 15
FDA Approves First US Digital Medicine System, FDA news release; 2017 Nov 14
FDA Approves Vraylar for Schizophrenia in Adults, Allergan plc news release; 2017 Nov 13
FDA Approves ADHD Drug for Patients 6 and Older, Neos Therapeutics news release; 2017 Sep 15