Health Canada Approves Otsuka and Lundbeck's REXULTI™ as a Treatment for Schizophrenia in Adults

Otsuka Pharmaceutical Co. and Lundbeck Canada announced that Health Canada issued a Notice of Compliance for REXULTI™ (brexpiprazole) for the treatment of schizophrenia in adults. REXULTI™ was discovered by Otsuka and co-developed with Lundbeck. It will be co-marketed by the two companies and is expected to become commercially available in Canada this spring.

REXULTI™ was studied in more than 2700 subjects with schizophrenia in phase II and III clinical trials, and the approval was supported by three completed placebo-controlled clinical phase III studies in the now-approved indication. In clinical trials, REXULTI™ was found to significantly improve both positive and negative symptoms.1,2,3

The efficacy, safety and tolerability of REXULTI™ was established in two 6-week, fixed-dose, phase III randomized, placebo-controlled clinical trials and one 52-week randomized withdrawal trial in subjects with schizophrenia who were experiencing an acute exacerbation of psychotic symptoms.1,2,3

"Brexpiprazole, a new treatment option for schizophrenia, with a unique mechanism of action provides us with new hope for patients suffering from this devastating illness," said Dr Ofer Agid, associate professor of psychiatry, Schizophrenia Program, Center for Addiction and Mental Health (CAMH), Department of Psychiatry, University of Toronto, Toronto, Ontario.

Schizophrenia is a severely debilitating and progressive mental illness4 affecting approximately 1% of the Canadian population—more than 350,000 Canadians.5,6,7

"It is always exciting to have a new treatment option for patients with schizophrenia since this is an illness where there are still patients who are not able to achieve remission", says Chris Summerville, CEO of the Schizophrenia Society of Canada.

Due to the underlying heterogeneity in the manifestations of schizophrenia, and differences in patient tolerability and response to treatment, patients are in need of additional treatment options.

"Psychiatric diseases remain a challenging therapeutic area where many people are unsatisfied with their treatments," noted Allison Rosenthal, general manager of Otsuka Canada Pharmaceutical Inc. "Today’s approval of REXULTI is another example of Otsuka and Lundbeck’s commitment to bringing new therapeutic alternatives to the mental health community."

"All treatment options require healthcare providers, patients and caregivers to balance efficacy and tolerability in managing their diseases," said Sylvie Pilon, vice president and general manager, Lundbeck Canada. "We are proud to introduce REXULTI to help adult patients living with schizophrenia."