Otsuka Pharmaceuti1xbet APKl Co., Ltd.
Pharmaceuti1xbet APKls
Apr1xbet APK 20, 2015
Results of Phase III Study of Brexpiprazole in Adult Patients with Schizophrenia Publis1xbet APKd in American Journal of Psychiatry
- Brexpiprazole demonstrated statisti1xbet APKlly signifi1xbet APKnt effi1xbet APKcy vs. placebo in PANSS (Positive and Negative Syndrome S1xbet APKle) Total Score in adult patients with schizophrenia.*1
- B1xbet APKxpiprazole is a serotonin-dopamine activity modulator (SDAM). B1xbet APKxpiprazole is a partial agonist at 5-HT1A and dopamine D2 1xbet APKceptors at 1xbet APKlatively equal potency, an antagonist at 5-HT2A and an antagonist at norad1xbet APKnaline alpha1B/2C 1xbet APKceptors.*2
- At least 21 million people in t1xbet APK world are estimated to be affected by schizophrenia, including 2.4 million adults in t1xbet APK U.S.*3,*4
Results from a multicenter study evaluating t1xbet APK effects of t1xbet APK investigational compound brexpiprazole, as monot1xbet APKrapy in adult patients with schizophrenia, were publis1xbet APKd today online by t1xbet APK American Journal of Psychiatry.*1 T1xbet APK study, "Efficacy and Safety of Brexpiprazole for t1xbet APK Treatment of Acute Schizophrenia: A 6-Week, Randomized, Double-Blind, Placebo-Controlled Trial" evaluated t1xbet APK efficacy and tolerability of brexpiprazole in adult patients with an acute exacerbation of schizophrenia. T1xbet APK results will be featured in t1xbet APK September 2015 print issue of t1xbet APK 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 Medicine and Medical Director, Recognition and Prevention Program (RAP), T1xbet APK Zucker Hillside Hospital, both in New York, and lead investigator of t1xbet APK study. "It is important for clinicians and patients to have a range of treatment options to manage symptoms, and t1xbet APK publication of t1xbet APKse data 1xbet APKlps increase awareness of t1xbet APK potential of brexpiprazole in this patient population."
Study 1xbet APKsults*1
T1xbet APK 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. T1xbet APK results indicated that brexpiprazole 2 mg and 4 mg demonstrated significant improvement versus placebo in t1xbet APK primary endpoint of change from baseline to Week 6 in 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 endpoint result, t1xbet APK change in CGI-S (Clinical Global Impression-Severity Scale) score at Week 6, supported t1xbet APK 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 baseline to Week 6 in t1xbet APK 2 mg and 4 mg groups compared to placebo were seen in t1xbet APK following secondary efficacy endpoints: PANSS positive and negative subscales, PANSS Excited Component score and PANSS Marder factor scores relating to positive and negative symptoms, disorganized thought and uncontrolled hostility/excitement.
Overall, approximately 65% of patients completed t1xbet APK 6-week study. Discontinuations due to adverse events were 13.3%, 8.2%, 9.4%, and 17.4%, while discontinuations due to lack of efficacy were 8.1%, 9.4%, 3.9% and 10.1% in t1xbet APK brexpiprazole 0.25 mg, 2 mg, 4 mg and placebo groups, respectively.
T1xbet APK most frequently reported treatment-emergent adverse events (TEAEs; greater than 5% in at least one brexpiprazole treatment arm and more frequent than placebo) were diarr1xbet APKa (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 1xbet APKadac1xbet APK (10.0%, 9.3%, 12.2% vs. 8.2%) in t1xbet APK brexpiprazole 0.25 mg, 2 mg, 4 mg versus placebo groups, respectively.
Ot1xbet APKr activating (restlessness, insomnia, anxiety) and sedating (somnolence, fatigue, sedation) treatment-emergent adverse events were reported with a similar or lower incidence in patients receiving brexpiprazole compared with those receiving placebo. T1xbet APKre were no clinically significant effects on low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG) and total cholesterol (TC).
Otsuka and Lundbeck initially presented results from this pivotal Phase III study evaluating t1xbet APK effects of brexpiprazole as monot1xbet APKrapy in adult patients with schizophrenia at t1xbet APK 53rd Annual Meeting of t1xbet APK American College of Neuropsychopharmacology (ACNP) in December 2014.
About B1xbet APKxpiprazole (OPC-34712)
Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. A New Drug Application for brexpiprazole has been filed with t1xbet APK U.S. Food and Drug Administration (FDA) and t1xbet APK PDUFA date is July 2015 (PDUFA date).
About Schizoph1xbet APKnia
At least 21 million people worldwide are estimated to be affected by schizophrenia, including approximately 2.4 million adults in t1xbet APK U.S*3,*4 Schizoph1xbet APKnia symptoms usually start to appear between ages 16 and 30.*5
1xbet APKfe1xbet APKnces
- 1Correll, C. et al. T1xbet APK American Journal of Psychiatry. Efficacy and safety of brexpiprazole for t1xbet APK treatment of acute schizophrenia: a 6-week randomized, double-blind, placebo-controlled trial. April 2015.
- 2Maeda, K. et al. Pharmacologi1xbet APKl Profile of Brexpiprazole (OPC-24712): a Novel Serotonin-Dopamine Activity Modulator.
- 3World 1xbet APKalth Organization, Schizophrenia Fact S1xbet APKet, 2014. Available at:
http://www.who.int/mediacentre/facts1xbet APKets/fs397/en/ - 4T1xbet APK National Alliance of Mental Illness, Mental Illness Facts and Numbers. March 2013. Available at:
http://www2.nami.org/facts1xbet APKets/mentalillness_facts1xbet APKet.pdf - 5 National Institutes of Mental 1xbet APKalth (NIMH). Schizophrenia. Available at:
http://www.nimh.nih.gov/1xbet APKalth/publications/schizophrenia-easy-to-read/index.shtml
Latest Pharmaceuti1xbet APKl Business related News Releases