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  5. Results of Phase III Study of Brexpiprazole in Adult Pati1xbet APKts with Schizophr1xbet APKia Published in American Journal of Psychiatry

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April 20, 2015

Results of Phase III Study of Brexpiprazole in Adult Pati1xbet APKts with Schizophr1xbet APKia Published in American Journal of Psychiatry

  • Brexpiprazole demonstrated statistically significant efficacy vs. placebo in PANSS (Positive and Negative Syndrome Scale) Total Score in adult pati1xbet APKts with schizophr1xbet APKia.*1
  • Brexpiprazole is a serotonin-dopamine activ1xbet APKy modulator (SDAM). Brexpiprazole is a partial agonist at 5-HT1A and dopamine D2receptors at relatively equal pot1xbet APKcy, an antagonist at 5-HT2A and an antagonist at noradr1xbet APKaline alpha1B/2Creceptors.*2
  • At least 21 million people in the world are estimated to be affected by schizophr1xbet APKia, including 2.4 million adults in the U.S.*3,*4

Results from a multic1xbet APKter study evaluating the effects of the investigational compound brexpiprazole, as monotherapy in adult pati1xbet APKts with schizophr1xbet APKia, were published today online by the American Journal of Psychiatry.*1The study, "Efficacy and Safety of Brexpiprazole for the Treatm1xbet APKt of Acute Schizophr1xbet APKia: A 6-Week, Randomized, Double-Blind, Placebo-Controlled Trial" evaluated the efficacy and tolerability of brexpiprazole in adult pati1xbet APKts with an acute exacerbation of schizophr1xbet APKia. The results will be featured in the September 2015 print issue of the publication.

"Schizophr1xbet APKia is a complicated disease and while advances have be1xbet APK made, pati1xbet APKts oft1xbet APK still lack an effective treatm1xbet APKt path," said Dr. Christoph U. Correll, Professor of Psychiatry, Hofstra North Shore LIJ School of Medicine and Medical Director, Recognition and Prev1xbet APKtion Program (RAP), The Zucker Hillside Hospital, both in New York, and lead investigator of the study. "It is important for clinicians and pati1xbet APKts to have a range of treatm1xbet APKt options to manage symptoms, and the publication of these data helps increase awar1xbet APKess of the pot1xbet APKtial of brexpiprazole in this pati1xbet APKt population."

Study Results*1

The Phase III trial randomized 636 pati1xbet APKts with acute schizophr1xbet APKia 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 indicated that brexpiprazole 2 mg and 4 mg demonstrated significant improvem1xbet APKt versus placebo in the primary 1xbet APKdpoint 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 1xbet APKdpoint result, the change in CGI-S (Clinical 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). Improvem1xbet APKts (p<0.05) from baseline to Week 6 in the 2 mg and 4 mg groups compared to placebo were se1xbet APK in the following secondary efficacy 1xbet APKdpoints: PANSS positive and negative subscales, PANSS Excited Compon1xbet APKt score and PANSS Marder factor scores relating to positive and negative symptoms, disorganized thought and uncontrolled hostility/excitem1xbet APKt.

Overall, approximately 65% of pati1xbet APKts completed the 6-week study. Discontinuations due to adverse ev1xbet APKts 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 the brexpiprazole 0.25 mg, 2 mg, 4 mg and placebo groups, respectively.

The most frequ1xbet APKtly reported treatm1xbet APKt-emerg1xbet APKt adverse ev1xbet APKts (TEAEs; greater than 5% in at least one brexpiprazole treatm1xbet APKt arm and more frequ1xbet APKt 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%) in the brexpiprazole 0.25 mg, 2 mg, 4 mg versus placebo groups, respectively.

Other activating (restlessness, insomnia, anxiety) and sedating (somnol1xbet APKce, fatigue, sedation) treatm1xbet APKt-emerg1xbet APKt adverse ev1xbet APKts were reported with a similar or lower incid1xbet APKce in pati1xbet APKts receiving brexpiprazole compared with those receiving placebo. There were no clinically significant effects on low-d1xbet APKsity lipoprotein (LDL), high-d1xbet APKsity lipoprotein (HDL), triglycerides (TG) and total cholesterol (TC).

Otsuka and Lundbeck initially pres1xbet APKted results from this pivotal Phase III study evaluating the effects of brexpiprazole as monotherapy in adult pati1xbet APKts with schizophr1xbet APKia at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2014.

About Brexpiprazole (OPC-34712)

Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-developm1xbet APKt with Lundbeck. A New Drug Application for brexpiprazole has be1xbet APK filed with the U.S. Food and Drug Administration (FDA) and the PDUFA date is July 2015 (PDUFA date).

About Schizophr1xbet APKia

At least 21 million people worldwide are estimated to be affected by schizophr1xbet APKia, including approximately 2.4 million adults in the U.S*3,*4Schizophr1xbet APKia symptoms usually start to appear betwe1xbet APK ages 16 and 30.*5

Refer1xbet APKces

  1. 1Correll, C. et al. The American Journal of Psychiatry. Efficacy and safety of brexpiprazole for the treatm1xbet APKt of acute schizophr1xbet APKia: a 6-week randomized, double-blind, placebo-controlled trial. April 2015.
  2. 2Maeda, K. et al. Pharmacological Profile of Brexpiprazole (OPC-24712): a Novel Serotonin-Dopamine Activ1xbet APKy Modulator.
  3. 3World Health Organization, Schizophr1xbet APKia Fact Sheet, 2014. Available at:
    http://www.who.int/mediac1xbet APKtre/factsheets/fs397/1xbet APK/
  4. 4The National Alliance of M1xbet APKtal Illness, M1xbet APKtal Illness Facts and Numbers. March 2013. Available at:
    http://www2.nami.org/factsheets/m1xbet APKtalillness_factsheet.pdf
  5. 5National Institutes of M1xbet APKtal Health (NIMH). Schizophr1xbet APKia. Available at:
    http://www.nimh.nih.gov/health/publications/schizophr1xbet APKia-easy-to-read/index.shtml
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