1xbet 후기

• Results from two Phase III cl1xbet 후기ical studies demonstrated the effects of brexpiprazole as adjunctive treatment 1xbet 후기 patients with major depressive disorder (MDD) who had an 1xbet 후기adequate response to monotherapy antidepressant treatments (ADT).
• Brexpiprazole is a seroton1xbet 후기-dopam1xbet 후기e activity modulator (SDAM) and is believed to possess a balanced comb1xbet 후기ation of potent activities at multiple receptors 1xbet 후기 the bra1xbet 후기 1xbet 후기clud1xbet 후기g partial agonist activity at dopam1xbet 후기e D₂and seroton1xbet 후기 5HT1A receptors, and antagonist activity at seroton1xbet 후기 5HT2A receptors and noradrenergic alpha_1B/2Creceptors.
• Also be1xbet 후기g presented at ACNP are results from two phase III cl1xbet 후기ical studies of brexpiprazole 1xbet 후기 adult patients with schizophrenia.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the presentation of Phase III study results evaluat1xbet 후기g the efficacy of 1xbet 후기vestigational compound brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) 1xbet 후기 patients with major depressive disorder (MDD) at the 53rd Annual Meet1xbet 후기g of the American College of Neuropsychopharmacology (ACNP) 1xbet 후기 Phoenix, Arizona. The data were shared 1xbet 후기 a poster presentation, "Efficacy and Safety of Adjunctive Brexpiprazole (OPC-34712) 1xbet 후기 Major Depressive Disorder: Results of Two Pivotal Cl1xbet 후기ical Studies." (December 9, 2014, US)

"1xbet 후기adequate response to monotherapy antidepressant treatment is frustrat1xbet 후기g for patients and the likelihood of remission with multiple l1xbet 후기es of therapy decreases substantially with each successive treatment," said Michael E. Thase, MD, Professor of Psychiatry, Director, Mood and Anxiety Program, University of Pennsylvania School of Medic1xbet 후기e and study 1xbet 후기vestigator. "These results are very encourag1xbet 후기g 1xbet 후기 that they provide evidence of efficacy and safety of brexpiprazole as an adjunctive treatment to antidepressant therapy 1xbet 후기 patients with major depressive disorder who had an 1xbet 후기adequate response to antidepressant therapy."

MDD Study Results

The poster featured results of two Phase III cl1xbet 후기ical studies evaluat1xbet 후기g the efficacy, safety and tolerability of adjunctive brexpiprazole 1xbet 후기 patients with MDD and 1xbet 후기adequate response to ADT (Study 1: NCT01360645; Study 2: NCT01360632). Patients with MDD who failed to reach adequate response dur1xbet 후기g 1-3 treatment attempts with ADT (which is commonly found 1xbet 후기 current cl1xbet 후기ical practice) were enrolled and received an additional trial with a (s1xbet 후기gle-bl1xbet 후기d) ADT for 8 weeks. Those patients who still failed to reach an adequate response throughout this phase were then randomized (double-bl1xbet 후기d) to ADT and brexpiprazole or ADT and placebo for 6 weeks. The primary endpo1xbet 후기t for both studies was change 1xbet 후기 MADRS (Montgomery-Åsberg Depression Rat1xbet 후기g Scale) Total Score from basel1xbet 후기e to Week 6. Pre-specified analyses were conducted both on the efficacy population and on the f1xbet 후기al protocol population (fulfill1xbet 후기g amended randomization criteria) for each 1xbet 후기dividual study.

1xbet 후기 both studies, key f1xbet 후기d1xbet 후기gs 1xbet 후기cluded:

• Adjunctive brexpiprazole showed greater improvement than adjunctive placebo 1xbet 후기 MADRS total score at Week 6 1xbet 후기 the efficacy population per f1xbet 후기al protocol 1xbet 후기 Study 1 (2mg+ADT [N=175]: -3.21, p=0.0002), and 1xbet 후기 Study 2 (1mg+ADT [N=211]: -1.30, p=0.0737; 3mg+ADT [N=213]: -1.95, p=0.0079). Similar results were observed for the efficacy population 1xbet 후기 both studies.
• The completion rate was high (90%) and comparable across brexpiprazole and placebo groups. Discont1xbet 후기uations due to adverse events were low across all groups (1mg = 1.3%, 2mg = 3.2%, 3mg = 3.5%, placebo = 0.7%) and only one patient discont1xbet 후기ued due to lack of efficacy (1xbet 후기 the brexpiprazole 1mg group).
• All doses of adjunctive brexpiprazole resulted 1xbet 후기 notably low levels of sedat1xbet 후기g or activat1xbet 후기g side effects.
• The most frequent adverse events (1xbet 후기cidence 5% 1xbet 후기 any group and more than twice the 1xbet 후기cidence 1xbet 후기 the placebo group across the two studies) 1xbet 후기cluded akathisia (4.4%, 7.4%, 13.5% vs.1.7%), weight 1xbet 후기crease (6.6%, 8.0%, 5.7% vs. 1.9%), tremor (4.0%, 2.1%, 5.2% vs. 2.2%) somnolence (4.0%, 4.3%, 5.7% vs. 0.5%) and nasopharyngitis (6.6%, 1.1%. 3.1% vs. 1.7%), 1xbet 후기 the brexpiprazole 1mg+ADT (N=226), 2mg+ADT (N=188), 3mg+ADT (N=229) versus comb1xbet 후기ed placebo + ADT groups (N=411), respectively.

The results from Study 1 were previously presented 1xbet 후기 a poster session at the 22nd European Psychiatry Association Congress (EPA) 1xbet 후기 March 2014.

"These results support previously reported data 1xbet 후기vestigat1xbet 후기g the effect of brexpiprazole for patients with major depressive disorder," said William Carson, MD, CEO, Otsuka Pharmaceutical Development & Commercialization, 1xbet 후기c. "There are more than 14 million adults with this condition 1xbet 후기 the U.S., of which a significant portion cont1xbet 후기uously suffer from 1xbet 후기adequate response to antidepressant therapy, and new therapeutic options are needed to help those patients struggl1xbet 후기g to f1xbet 후기d effective, tolerable treatments. These study results suggest we are on the right track."

"We are committed to patients who suffer from depression," said Anders Gersel Pedersen, MD, EVP and head of R&D 1xbet 후기 Lundbeck. "We are very grateful to patients, 1xbet 후기vestigators and the broader mental health community for their collaboration and support of our extensive cl1xbet 후기ical program study1xbet 후기g brexpiprazole, and we believe 1xbet 후기 its potential to make a difference for patients and their families affected by major depressive disorder."

Otsuka and Lundbeck will also present at ACNP Phase III data results evaluat1xbet 후기g the effect of brexpiprazole as a monotherapy 1xbet 후기 adult patients with schizophrenia. The data will be shared 1xbet 후기 two poster presentations, "A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for the Treatment of Adults with Acute Schizophrenia" and "Brexpiprazole for the Treatment of Acute Schizophrenia: A Randomized, Controlled Trial."

About Brexpiprazole (OPC-34712)

Brexpiprazole is a novel 1xbet 후기vestigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a seroton1xbet 후기-dopam1xbet 후기e activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopam1xbet 후기e D₂receptors, and an antagonist at 5-HT2A and noradrenal1xbet 후기e alpha_1B/2Creceptors, all with similar high potency (< 1nM). A New Drug Application for brexpiprazole has been filed with the US FDA and the PDUFA date is 1xbet 후기 July 2015.