Allergan Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia
- Category: Small Molecules
- Published on Monday, 13 November 2017 15:35
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-- Label Expansion Includes New Data Showing Long-Term VRAYLAR Therapy Delayed Time to Relapse Compared to Placebo Over the Course of up to 72 Weeks --
DUBLIN, Ireland I November 13, 2017 I Allergan plc (NYSE: AGN) today announced that the U.S. 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 U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.1
"Schizophrenia is one of the most challenging mental health disorders to manage – particularly due to the complexity of patient symptoms, varying response to treatment and high rates of relapse," said Dr. Herbert Meltzer, Professor of Psychiatry and Behavioral Sciences at Northwestern Feinberg School of Medicine. "The goal of clinicians is to minimize relapses, which can cause significant personal distress, and can often have serious implications for a patient's health. The approval of VRAYLAR for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options."
Without maintenance treatment, 60 – 70 percent of schizophrenia patients relapse within one year. Once a schizophrenia patient reaches the stable or maintenance phase of treatment, it is important for the physician to develop a long-term treatment management plan to minimize relapse risk, monitor for and reduce severity of side effects, and address residual symptoms where possible.2
The efficacy of VRAYLAR in the maintenance treatment of schizophrenia was based on an up to 72-week, multinational, double-blind, placebo-controlled, randomized withdrawal study in the prevention of relapse in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized either to continue their VRAYLAR dose (3, 6 or 9 mg per day) or be switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to relapse during the randomized, double blind phase.1
The study demonstrated that VRAYLAR y significantly delayed the time to relapse compared to placebo (P=0.0010). Relapse occurred in nearly twice as many placebo-treated patients (49.5%, n=49/99) as VRAYLAR-treated (29.7%, n=30/101) patients. The safety results were consistent with the profile observed to-date for VRAYLAR.1
"The differences in how people with schizophrenia respond to treatment underscores the importance of having additional treatment options," said David Nicholson, Chief Research & Development Officer at Allergan. "We are pleased that the FDA has recognized the benefits of VRAYLAR for maintenance treatment of adults with schizophrenia. This approval demonstrates our continued investment in VRAYLAR, as well as our commitment to developing treatments that address unmet needs facing people living with mental illness."
Schizophrenia is a chronic and disabling disorder that affects about 2.4 million American adults.3 It imposes significant burden on patients, their families and society. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders and movement disorders), negative symptoms (such as loss of motivation and social withdrawal) and cognitive symptoms (problems with executive functioning, focusing and working memory).4
About VRAYLAR™ (cariprazine)
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 cariprazine have shown that it acts as a partial agonist with high binding affinity at dopamine D3, dopamine D2, and serotonin 5-HT1A receptors. Cariprazine demonstrated up to ~8-fold greater in vitro affinity for dopamine D3 vs D2 receptors. Cariprazine 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. Cariprazine shows lower binding affinity to the serotonin 5-HT2C and α1A- 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 U.S. and Canada.
Visit www.VRAYLAR.com for more information.