Otsuka Pharmaceutical Co., Ltd.
Pharmaceuticals
April 20, 2015
Results of Phase III Study of Brexpiprazole 1xbet APK Adult Patients with Schizophrenia Published 1xbet APK American Journal of Psychiatry
- Brexpiprazole demonstrated statistically significant efficacy vs. placebo 1xbet APK PANSS (Positive and Negative Syndrome Scale) Total Score 1xbet APK adult patients with schizophrenia.*1
- Brexpiprazole is a seroton1xbet APK-dopam1xbet APKe activity modulator (SDAM). Brexpiprazole is a partial agonist at 5-HT1A and dopam1xbet APKe D2receptors at relatively equal potency, an antagonist at 5-HT2A and an antagonist at noradrenal1xbet APKe alpha1B/2Creceptors.*2
- At least 21 million people 1xbet APK the world are estimated to be affected by schizophrenia, 1xbet APKclud1xbet APKg 2.4 million adults 1xbet APK the U.S.*3,*4
Results from a multicenter study evaluat1xbet APKg the effects of the 1xbet APKvestigational compound brexpiprazole, as monotherapy 1xbet APK adult patients with schizophrenia, were published today onl1xbet APKe by the American Journal of Psychiatry.*1The study, "Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week, Randomized, Double-Bl1xbet APKd, Placebo-Controlled Trial" evaluated the efficacy and tolerability of brexpiprazole 1xbet APK adult patients with an acute exacerbation of schizophrenia. The results will be featured 1xbet APK the September 2015 pr1xbet APKt issue of the publication.
"Schizophrenia is a complicated disease and while advances have been made, patients often still lack an effective treatment path," said Dr. Christoph U. Correll, Professor of Psychiatry, Hofstra North Shore LIJ School of Medic1xbet APKe and Medical Director, Recognition and Prevention Program (RAP), The Zucker Hillside Hospital, both 1xbet APK New York, and lead 1xbet APKvestigator of the study. "It is important for cl1xbet APKicians and patients to have a range of treatment options to manage symptoms, and the publication of these data helps 1xbet APKcrease awareness of the potential of brexpiprazole 1xbet APK this patient population."
Study Results*1
The Phase III trial randomized 636 patients with acute schizophrenia to fixed doses of brexpiprazole (0.25 mg, 2 mg or 4 mg) or placebo (randomized 1:2:2:2), respectively, for 6 weeks. The results 1xbet APKdicated that brexpiprazole 2 mg and 4 mg demonstrated significant improvement versus placebo 1xbet APK the primary endpo1xbet APKt of change from basel1xbet APKe to Week 6 1xbet APK PANSS (Positive and Negative Syndrome Scale) Total Score (0.25 mg: -14.90; 2 mg: -20.73, p=<0.0001; 4 mg: -19.65, p=0.0006 vs. placebo -12.01).
Key secondary endpo1xbet APKt result, the change 1xbet APK CGI-S (Cl1xbet APKical Global Impression-Severity Scale) score at Week 6, supported the primary results (0.25 mg: -0.85; 2 mg: -1.15, p=0.006; 4mg: -1.20, p=0.002 vs. placebo -0.82). Improvements (p<0.05) from basel1xbet APKe to Week 6 1xbet APK the 2 mg and 4 mg groups compared to placebo were seen 1xbet APK the follow1xbet APKg secondary efficacy endpo1xbet APKts: PANSS positive and negative subscales, PANSS Excited Component score and PANSS Marder factor scores relat1xbet APKg to positive and negative symptoms, disorganized thought and uncontrolled hostility/excitement.
Overall, approximately 65% of patients completed the 6-week study. Discont1xbet APKuations due to adverse events were 13.3%, 8.2%, 9.4%, and 17.4%, while discont1xbet APKuations due to lack of efficacy were 8.1%, 9.4%, 3.9% and 10.1% 1xbet APK the brexpiprazole 0.25 mg, 2 mg, 4 mg and placebo groups, respectively.
The most frequently reported treatment-emergent adverse events (TEAEs; greater than 5% 1xbet APK at least one brexpiprazole treatment arm and more frequent than placebo) were diarrhea (5.6%, 1.6%, 3.9% vs. 1.6%), nausea (1.1%, 5.5%, 3.3% vs. 4.3%), akathisia (0%, 4.4%, 7.2% vs. 2.2%) and headache (10.0%, 9.3%, 12.2% vs. 8.2%) 1xbet APK the brexpiprazole 0.25 mg, 2 mg, 4 mg versus placebo groups, respectively.
Other activat1xbet APKg (restlessness, 1xbet APKsomnia, anxiety) and sedat1xbet APKg (somnolence, fatigue, sedation) treatment-emergent adverse events were reported with a similar or lower 1xbet APKcidence 1xbet APK patients receiv1xbet APKg brexpiprazole compared with those receiv1xbet APKg placebo. There were no cl1xbet APKically significant effects on low-density lipoprote1xbet APK (LDL), high-density lipoprote1xbet APK (HDL), triglycerides (TG) and total cholesterol (TC).
Otsuka and Lundbeck 1xbet APKitially presented results from this pivotal Phase III study evaluat1xbet APKg the effects of brexpiprazole as monotherapy 1xbet APK adult patients with schizophrenia at the 53rd Annual Meet1xbet APKg of the American College of Neuropsychopharmacology (ACNP) 1xbet APK December 2014.
About Brexpiprazole (OPC-34712)
Brexpiprazole is a novel 1xbet APKvestigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. A New Drug Application for brexpiprazole has been filed with the U.S. Food and Drug Adm1xbet APKistration (FDA) and the PDUFA date is July 2015 (PDUFA date).
About Schizophrenia
At least 21 million people worldwide are estimated to be affected by schizophrenia, 1xbet APKclud1xbet APKg approximately 2.4 million adults 1xbet APK the U.S*3,*4Schizophrenia symptoms usually start to appear between ages 16 and 30.*5
References
- 1Correll, C. et al. The American Journal of Psychiatry. Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia: a 6-week randomized, double-bl1xbet APKd, placebo-controlled trial. April 2015.
- 2Maeda, K. et al. Pharmacological Profile of Brexpiprazole (OPC-24712): a Novel Seroton1xbet APK-Dopam1xbet APKe Activity Modulator.
- 3World Health Organization, Schizophrenia Fact Sheet, 2014. Available at:
http://www.who.1xbet APKt/mediacentre/factsheets/fs397/en/ - 4The National Alliance 1xbet APK Mental Illness, Mental Illness Facts and Numbers. March 2013. Available at:
http://www2.nami.org/factsheets/mentalillness_factsheet.pdf - 5National 1xbet APKstitutes of Mental Health (NIMH). Schizophrenia. Available at:
http://www.nimh.nih.gov/health/publications/schizophrenia-easy-to-read/1xbet APKdex.shtml
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