Allergan : FDA Approves New Drug To Treat Schizophrenia And Bipolar Disorder

(RTTNews) - Allergan plc (AGN) and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration has approved VRAYLAR or cariprazine capsules, an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.

Bipolar I disorder and schizophrenia are chronic and disabling mental health disorders. Bipolar I disorder, also known as manic-depressive illness, is a disorder of the brain that is characterized by fluctuations in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Schizophrenia is characterized by delusions, hallucinations, disorganized speech and behavior, and other symptoms that cause social or occupational dysfunction.

The FDA approval of VRAYLAR is based on the results of three 3-week controlled trials in adults with manic or mixed episodes of bipolar I disorder and three 6-week placebo-controlled trials in adults with schizophrenia. In these clinical trials involving more than 2,700 adults, VRAYLAR demonstrated improvement compared to placebo as measured by Young Mania Rating Scale total scores in patients with bipolar mania and by Positive and Negative Syndrome Scale (PANSS) total scores in patients with schizophrenia. VRAYLAR also demonstrated efficacy as measured by the Clinical Global Impressions-Severity (CGI-S) rating scale, the secondary efficacy endpoints for both conditions.

Vraylar and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis. Neither Vraylar nor any other drug in this class is approved to treat such patients.

The most common side effects reported by participants receiving Vraylar in the clinical trials for schizophrenia were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements. The most common side effects reported by trial participants receiving Vraylar for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.

VRAYLAR was discovered and co-developed by Gedeon Richter Plc and is licensed to Actavis, now Allergan, in the U.S. and Canada.

Cariprazine is also being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.