February 20, 2017
Otsuka Pharmaceutical Co., Ltd.
Health Canada Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as a Treatment for Schizophrenia in Adults
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Canada announce 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 illness.*4 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.
REXULTI is given in a once-daily oral dose with a well-defined titration schedule that can be taken with or without food.*8
REXULTI(brexpiprazole) is a new molecule (i.e., not a metabolite or isomer) discovered by Otsuka and co-developed by Otsuka and Lundbeck. The mechanism of action for REXULTI™ in the treatment of schizophrenia is unknown. However, the efficacy of REXULTI may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. In addition, REXULTI™ exhibits high affinity (subnanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.*9
- 1Kane JM, Skuban A, Ouyang J, Hobart M, Pfister S et al. (2015) A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia. Schizophr Res 164 (1-3): 127-135.
- 2Correll CU, Skuban A, Ouyang J, Hobart M, Pfister S et al. (2015) Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia: A 6-Week randomized, double-blind, placebo-controlled trial. Am J Psychiatry 172 (9): 870-880.
- 3Fleischhacker WW, Hobart M, Ouyang J, Forbes A, Pfister S et al. (2016) Efficacy and safety of brexpiprazole (OPC-34712) as maintenance treatment in adults with schizophrenia: a randomized, double-blind, placebo-controlled study. Int J Neuropsychopharmacology (2017) 20(1): 11-21.
- 4American Psychiatric Association (2013) Diagnostic and Statistical Manual of Mental Disorders. 5th Ed. Arlington, VA: American Psychiatric Association.
- 5Mueser KT, McGurk SR. Schizophrenia. Lancet 2004;363:2063-72.
- 6Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D et al. (2005) The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin 21 (12): 2017-2028.
- 7Mood Disorders Society of Canada. Quick facts on mental illness and addictions in Canada, 3rd Edition, Nov 2009. (Accessed December 19, 2016, at https://mdsc.ca/quick-facts/.)
- 8Otsuka Canada Pharmaceutical Inc. REXULTI™ (brexpiprazole) product monograph. February 16, 2017.
- 9Maeda, K. et al. Pharmacological profile of brexpiprazole (OPC-2471234712): a novel serotonin-dopamine activity modulator. Poster presentation at American Psychiatric Association annual meeting, May 3-7, 2014.
Information in this news release was current as of the original release date.