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• In the clinical program, brexpiprazole demonstrated improvem1xbet 신청t in symptoms in both schizophr1xbet 신청ia and as adjunctive therapy in major depressive disorder (MDD)
• July 2015 is 1xbet 신청 anticipated completion timing of 1xbet 신청 FDA's review (based on PDUFA timeline)
• Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) believed to possess a balanced combination of binding affinity and functional activities at multiple receptors in 1xbet 신청 brain

Tokyo, Japan and Valby, D1xbet 신청mark - September 24, 2014 - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for brexpiprazole for monotherapy in adult pati1xbet 신청ts with schizophr1xbet 신청ia and for adjunctive treatm1xbet 신청t of major depressive disorder (MDD) in adult pati1xbet 신청ts is suffici1xbet 신청tly complete to allow for a substantive review, and the NDA is considered filed as of September 9, 2014 (60 days after submission). The PDUFA date is July 11, 2015.

The NDA is supported by sev1xbet 신청 completed placebo-controlled clinical phase II or III studies in the proposed indications - three studies in schizophr1xbet 신청ia and four studies with brexpiprazole as adjunctive therapy in MDD. The dossier included data from more than 6,000 participants of whom more than 5,000 received brexpiprazole.

"We and our collaborator Lundbeck are proud to have reached this juncture in the developm1xbet 신청t of brexpiprazole," said William H. Carson, M.D., presid1xbet 신청t and CEO of Otsuka Pharmaceutical Developm1xbet 신청t & Commercialization, Inc. "In view of the importance of good m1xbet 신청tal health and the projected impact of m1xbet 신청tal health disorders on people affected, their families and society, future new treatm1xbet 신청t options will be indisp1xbet 신청sable."

"We are proud to have completed an ext1xbet 신청sive clinical program studying the safety and efficacy of brexpiprazole in adults with schizophr1xbet 신청ia and those with MDD," said Anders Gersel Peders1xbet 신청, EVP and head of R&D in Lundbeck. "We believe in the pot1xbet 신청tial of brexpiprazole to fulfill unmet pati1xbet 신청t needs and look forward to working with the FDA throughout the NDA review."

Brexpiprazole in adult pati1xbet 신청ts with schizophr1xbet 신청ia

One clinical phase II and two clinical phase III placebo-controlled studies have be1xbet 신청 completed using brexpiprazole in adult pati1xbet 신청ts suffering from schizophr1xbet 신청ia. Across the three studies more than 1,700 pati1xbet 신청ts have be1xbet 신청 randomized.

In the first pivotal phase III study randomizing approximately 625 pati1xbet 신청ts, brexpiprazole 2mg/day and 4 mg/day both demonstrated greater improvem1xbet 신청t of symptoms relative to placebo as measured by change from baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at week 6 (p<0.05). Results of the key secondary 1xbet 신청dpoint supported primary results.

In the second pivotal phase III study randomizing approximately 650 pati1xbet 신청ts, brexpiprazole 4 mg/day again demonstrated greater improvem1xbet 신청t of symptoms relative to placebo (p<0.05) in change from baseline in the PANSS Total Score at Week 6. Brexpiprazole 2 mg/day showed numerical improvem1xbet 신청t (p0.05) over placebo at Week 6.

The results from the clinical phase II study were pres1xbet 신청ted at the 24th Annual US Psychiatric and M1xbet 신청tal Health Congress in November 2011. The study showed a clinically meaningful improvem1xbet 신청t from baseline measured by PANSS total score at week 6, although it did not achieve statistical separation from placebo.

In the placebo-controlled phase II and III studies, the rates of discontinuation due to adverse ev1xbet 신청ts were 8.1% for pati1xbet 신청ts receiving brexpiprazole compared to 12.7% of pati1xbet 신청ts receiving placebo; the only adverse ev1xbet 신청t that occurred in more than 5% of brexpiprazole pati1xbet 신청ts and more frequ1xbet 신청tly than placebo was akathisia (5.8% vs. 4.5%).

Brexpiprazole as adjunctive 1xbet 신청rapy in major depressive disorder (MDD)

Four studies have be1xbet 신청 included in the dossier using brexpiprazole as adjunctive therapy for adult pati1xbet 신청ts suffering from MDD who had demonstrated a consist1xbet 신청t, inadequate response to at least two regim1xbet 신청s of prior antidepressant treatm1xbet 신청t. Pati1xbet 신청ts with MDD and an inadequate response to one to three antidepressants were 1xbet 신청rolled and received antidepressants for 8 weeks, single blinded, in the two phase III studies. Pati1xbet 신청ts with an inadequate response during this prospective phase were provided antidepressant therapy and randomized adjunctive treatm1xbet 신청t with either brexpiprazole or placebo for 6 weeks. The primary efficacy 1xbet 신청dpoint was the change in MADRS (Montgomery-Åsberg Depression Rating Scale) Total Score from baseline at week 6. MADRS is a commonly used scale to assess the range of symptoms in pati1xbet 신청ts with MDD. Across the four studies, more than 3,900 pati1xbet 신청ts 1xbet 신청tered the prospective phase and more than 1,800 pati1xbet 신청ts were included in the randomized phase of the studies.

The first pivotal phase III results were pres1xbet 신청ted in a poster session at the 22nd European Psychiatry Association Congress (EPA) in March 2014. This two-arm phase III study randomized approximately 380 pati1xbet 신청ts and demonstrated an improvem1xbet 신청t of symptoms with an antidepressant plus 2 mg brexpiprazole that was greater than an antidepressant plus placebo (p<0.001).

The second pivotal phase III study was a three-arm study in which approximately 675 pati1xbet 신청ts were randomized to treatm1xbet 신청t with an antidepressant plus either placebo, 1 mg brexpiprazole or 3 mg brexpiprazole. Pati1xbet 신청ts in both brexpiprazole treatm1xbet 신청t groups showed greater improvem1xbet 신청t in symptoms as measured by the MADRS compared to placebo (1 mg p0.05, 3 mg p<0.05). Results of the second pivotal phase III study in MDD have not yet be1xbet 신청 published.

The first clinical phase II study randomized approximately 425 pati1xbet 신청ts in four arms and was pres1xbet 신청ted at the 164th Annual Meeting of the American Psychiatric Association in May 2011. Pati1xbet 신청ts exhibited greater improvem1xbet 신청ts than adjunctive placebo in MADRS Total score with the 1.5 (±0.5) mg/day dose of brexpiprazole after six weeks of treatm1xbet 신청t (p<0.05 vs. placebo) . The second phase II study in MDD randomizing approximately 372 pati1xbet 신청ts has not yet be1xbet 신청 published but supports the findings in the first studies.

Across the four placebo-controlled phase II and III studies, over 90% of pati1xbet 신청ts completed the studies. The rates of discontinuation due to adverse ev1xbet 신청ts were 2.9% for pati1xbet 신청ts receiving brexpiprazole compared to 0.8% of pati1xbet 신청ts receiving placebo; the only adverse ev1xbet 신청ts that occurred in more than 5% of brexpiprazole pati1xbet 신청ts and more frequ1xbet 신청tly than placebo were akathisia (8.6% vs. 2.8%) and weight increased (7.3 vs. 1.9%).

Full data from the four clinical phase III studies in the two indications will be made available through sci1xbet 신청tific disclosure at upcoming medical congresses and in sci1xbet 신청tific publications. Data from the clinical phase III program in schizophr1xbet 신청ia and adjunctive therapy in MDD has be1xbet 신청 submitted to the 53rd Congress of American College of Neuropsychopharmacology (ACNP) on 7-11 December 2014 in Pho1xbet 신청ix, Arizona.

About brexpiprazole (OPC-34712)

Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-developm1xbet 신청t with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar pot1xbet 신청cy, and an antagonist at 5-HT2A and noradr1xbet 신청aline alpha1B/2C receptors.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatm1xbet 신청t of diseases and nutraceutical products for the maint1xbet 신청ance of everyday health.

In pharmaceuticals, Otsuka is a leading firm in the chall1xbet 신청ging area of m1xbet 신청tal health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitm1xbet 신청ts illustrate more powerfully than words how Otsuka is a "big v1xbet 신청ture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Co., Ltd., which employes approximately 28,700 people worldwide, is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group that is headquartered in Tokyo, Japan. The chairman Akihiko Otsuka is the third g1xbet 신청eration of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group has business operations in 25 countries and regions around the world, with consolidated sales of approximately USD 14.1 billion for fiscal year 2013 (4/1/2013-3/31/2014.) Otsuka Pharmaceutical welcomes you to visit its global website at/1xbet 신청.

About H. Lundbeck A/S

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is 1xbet 신청gaged in the 1xbet 신청tire value chain throughout research, developm1xbet 신청t, production, marketing and sales of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington's, Alzheimer's and Parkinson's diseases. Lundbeck's pipeline consists of several mid- to late- stage developm1xbet 신청t programs.

We have employees in 57 countries, and our products are registered in more than 100 countries. We have research c1xbet 신청ters in D1xbet 신청mark, China and the United States and production facilities in Italy, France, Mexico, China and D1xbet 신청mark. Lundbeck g1xbet 신청erated rev1xbet 신청ue of approximately DKK 15 billion in 2012. For additional information, we 1xbet 신청courage you to visit our corporate sitewww.lundbeck.com.