Allergan plc, a leading global pharmaceutical company, announced that Vraylar (cariprazine), a once-daily oral atypical antipsychotic, is now available by prescription in pharmacies throughout the US. Vraylar was approved by the US Food and Drug Administration in September 2015 for the treatment of acute manic or mixed episodes of bipolar I disorder and schizophrenia in adults.

"We are excited that Vraylar is now available to the millions of people living with bipolar I disorder and schizophrenia," said David Nicholson, president and EVP, global R&D at Allergan. "This launch reinforces Allergan's rich heritage in mental health and our ongoing commitment to developing treatment options that address unmet needs for people who are affected by these serious conditions."

Bipolar I disorder, also known as manic-depressive illness, and schizophrenia are among the most challenging mental health disorders to manage, and together affect approximately 8.5 million adults in the United States. Treatment for both illnesses is often complicated by high rates of relapse and a high degree of variability in disease course and severity, as well as patient symptoms and response to treatment.

"The important differences in how patients with bipolar I disorder and schizophrenia respond to treatment underscore the need for more treatment options for these serious illnesses ," said Gary Sachs, MD, founding director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical school. "The availability of Vraylar gives physicians access to a new treatment option that I think will be appealing to patients who are living with these often devastating conditions."

The safety and efficacy of Vraylar was studied in a clinical trial programme which included more than 2,700 adult patients suffering from schizophrenia or bipolar mania. Vraylar will be commercially available in 30 count bottles in 1.5mg, 3mg, 4.5mg and 6mg and a 7 count mixed blister pack (one 1.5mg and six 3mg tablets).

Vraylar is an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day.

While the mechanism of action of Vraylar in schizophrenia and bipolar I disorder is unknown, the efficacy of Vraylar could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.

Pharmacodynamic studies with Vraylar have shown that it acts as a partial agonist at dopamine D3, dopamine D2, and serotonin 5-HT1A receptors with high binding affinity. Vraylar demonstrated up to ~8-fold greater in vitro affinity for dopamine D3 vs D2 receptors. Vraylar also acts as an antagonist at serotonin 5-HT2B and 5-HT2A receptors with high and moderate binding affinity, respectively as well as it binds to the histamine H1 receptors. Vraylar shows lower binding affinity to the serotonin 5-HT2C and a1A- adrenergic receptors and has no appreciable affinity for cholinergic muscarinic receptors. The clinical significance of these in vitro data is unknown.

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

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