Brexpiprazole Phase III results in Schizophrenia- Otsuka + Lundbeck

Otsuka Pharmaceutical Co.,Ltd. and H. Lundbeck A/S announced the presentation of Phase III study results evaluating the effects of an investigational compound, brexpiprazole, as monotherapy in adult patients with Schizophrenia at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in two poster presentations.

The poster, "Brexpiprazole for the Treatment of Acute Schizophrenia: A Randomized, Controlled Trial," (NCT01396421) evaluated the efficacy and tolerability of brexpiprazole in adult patients with acute Schizophrenia. The pivotal Phase III trial randomized 636 patients with acute Schizophrenia to fixed doses of brexpiprazole (0.25mg, 2mg or 4mg) or placebo (randomized 1:2:2:2) respectively for 6 weeks. The results indicated: � Brexpiprazole 4mg and 2mg demonstrated greater improvement than placebo in the primary endpoint of change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (4mg: -19.65, p=0.0006 and 2mg: -20.73, p=<0.0001 vs. placebo -12.01 0.25mg was similar to placebo -14.90>

The poster, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for the Treatment of Adults with Acute Schizophrenia," (NCT01393613) showcased results from a pivotal Phase III trial that randomized 674 patients with acute Schizophrenia to fixed doses of brexpiprazole (1mg, 2mg, 4mg) or placebo (2:3:3:3) respectively for 6 weeks. The results indicated: � Brexpiprazole 4mg showed improvement over placebo in the primary endpoint of PANSS Total Score from baseline to Week 6 (-20.0 vs. -13.5, p=0.0022), while the 2mg (-16.6) and 1mg (-16.9) doses showed numeric improvement versus placebo (-13.5, p>0.05).

Otsuka and Lundbeck also presented results from two Phase III studies evaluating the effect of brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) at ACNP. The data were shared in a poster presentation, "Efficacy and Safety of Adjunctive Brexpiprazole (OPC-34712) in Major Depressive Disorder: Results of Two Pivotal Clinical Studies.