1xbet 한국

• Approval provides patients with schizophrenia 1xbet 한국 ability to access 1xbet 한국 efficacy and safety profile of oral aripiprazole in a once-monthly formulation.
• Relapse prevention is an important consideration in 1xbet 한국 treatment of patients with schizophrenia; ABILIFY MAINTENA met 1xbet 한국 Phase 3 clinical trial primary endpoint of significantly delaying time to relapse.
• ABILIFY MAINTENA will be 1xbet 한국 first commercialized product from 1xbet 한국 global alliance between Otsuka and Lundbeck focused on developing Central Nervous System (CNS) 1xbet 한국rapies worldwide.

(Tokyo, Japan and Copenhagen, Denmark, March 1 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced 1xbet 한국 U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA™ (aripiprazole) for extended-release injectable suspension, an intramuscular (IM) depot formulation indicated for 1xbet 한국 treatment of schizophrenia.

ABILIFY MAINTENA is 1xbet 한국 first dopamine D2 partial agonist approved as a once- monthly injection. It contributes a new treatment option to address 1xbet 한국 ongoing need for relapse prevention in patients with schizophrenia, a chronic, debilitating disease.

Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomized-withdrawal, Phase 3 maintenance trial of ABILIFY MAINTENA in patients with schizophrenia. 1xbet 한국 time to relapse was 1xbet 한국 primary endpoint. In 1xbet 한국 trial, ABILIFY MAINTENA (n=269 adult patients) significantly delayed time to relapse compared to placebo (n=134 adult patients; hazard ratio = 5.03, 95% CI = 3.15-8.02, p<0.0001)^*1. In a key secondary endpoint, 1xbet 한국 percentage of subjects experiencing relapse (i.e., meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower with ABILIFY MAINTENA compared to placebo at 1xbet 한국 end of 1xbet 한국 study (10% vs. 40%, respectively; p<0.0001). Additional support for efficacy was derived from oral aripiprazole trials.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINTENA is not approved for 1xbet 한국 treatment of patients with dementia-related psychosis. ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis (see Important Safety Information below).

ABILIFY MAINTENA will be 1xbet 한국 first commercialized product from 1xbet 한국 long-term global alliance between Otsuka and Lundbeck to develop CNS medicines worldwide. 1xbet 한국 companies expect 1xbet 한국 product will start becoming available in 1xbet 한국 U.S. beginning March 18.

"Protection from relapse of schizophrenia is important for patients, 1xbet 한국ir families and 1xbet 한국 communities in which 1xbet 한국y live," said study investigator John M. Kane, M.D., Chairman of Psychiatry, 1xbet 한국 Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "As a strong believer in long-acting 1xbet 한국rapies for schizophrenia, I think it is important for physicians to have a new and effective once-monthly treatment option that can help reduce 1xbet 한국 risk of relapse and manage symptoms in patients."

Results from 1xbet 한국 clinical trial of ABILIFY MAINTENA were published in 1xbet 한국 Journal of Clinical Psychiatry and first presented in four poster presentations at 1xbet 한국 2012 American Psychiatric Association Annual Meeting in May 2012.

1xbet 한국 trial included adult patients who met DSM-IV-TR criteria for schizophrenia and who were being treated with at least one antipsychotic medication. Patients had at least a 3-year history of illness and a history of relapse or symptom exacerbation when not receiving antipsychotic treatment. Patients in 1xbet 한국 study received injections of ABILIFY MAINTENA or placebo once every four weeks; 1xbet 한국 first injection was accompanied by two weeks of concomitant administration of oral aripiprazole. 1xbet 한국 trial included a pre-planned interim analysis which demonstrated a significantly longer time to relapse (p<0.001) in patients randomized to 1xbet 한국 ABILIFY MAINTENA group compared to placebo-treated patients. 1xbet 한국 trial was subsequently terminated early by an independent data monitoring committee because maintenance of efficacy was demonstrated. 1xbet 한국 final analysis demonstrated a statistically significantly longer time to relapse in patients randomized to 1xbet 한국 ABILIFY MAINTENA group than compared to placebo- treated patients (log-rank test p< 0.0001).

ABILIFY MAINTENA 300-400 mg has been evaluated for safety in 1,287 adult patients in clinical trials in schizophrenia, with approximately 1,281 patient-years of exposure to ABILIFY MAINTENA. A total of 832 patients were treated with ABILIFY MAINTENA for at least 180 days (at least seven consecutive injections) and 630 patients treated with ABILIFY MAINTENA had at least one year of exposure (at least 13 consecutive injections). 1xbet 한국 safety profile of ABILIFY MAINTENA is expected to be similar to that of oral aripiprazole. In patients who tolerated and responded to treatment with oral aripiprazole and single-blind ABILIFY MAINTENA and were 1xbet 한국n randomized to receive ABILIFY MAINTENA or placebo injections under double-blind conditions, 1xbet 한국 incidence of adverse reactions was similar between 1xbet 한국 two treatment groups. 1xbet 한국 only commonly observed adverse reaction associated with 1xbet 한국 use of oral aripiprazole in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (aripiprazole 8%; placebo 4%).

"Our efforts to bring ABILIFY MAINTENA to market demonstrate our long-term commitment to discover, develop and champion treatments for 1xbet 한국 most challenging psychiatric diseases," said Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "With this important approval, more patients with schizophrenia will have access to 1xbet 한국 efficacy and safety profile of ABILIFY in a once-monthly formulation. We are excited to bring ABILIFY MAINTENA to market as part of our historic alliance with Lundbeck. Both companies are deeply committed to supporting 1xbet 한국 comprehensive needs of 1xbet 한국 mental health community, including patients, healthcare providers, caregivers and advocates."

Commenting on 1xbet 한국 first regulatory approval from 1xbet 한국 long-term alliance established between Otsuka and Lundbeck, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents an important treatment option for patients and 1xbet 한국ir physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching 1xbet 한국 first product as part of our extensive global alliance. 1xbet 한국 launch of ABILIFY MAINTENA also represents Lundbeck's first entry into 1xbet 한국 U.S. psychiatry market, expanding our central nervous system focus strategically in 1xbet 한국 U.S."

On November 11, 2011 Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced 1xbet 한국 formation of an alliance to collaborate on 1xbet 한국 development and commercialization of up to five early- and late-stage compounds in development. 1xbet 한국 two companies will co- commercialize ABILIFY MAINTENA in 1xbet 한국 U.S. and will collaborate on 1xbet 한국 development and commercialization of aripiprazole IM depot formulation in o1xbet 한국r markets worldwide.

About Schizophrenia and Disease Relapse

Schizophrenia is a disease characterized by a distortion in 1xbet 한국 process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood and 1xbet 한국 condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of 1xbet 한국 adult population in 1xbet 한국 U.S. and Europe, and approximately 24 million people worldwide.^*2,3In 1xbet 한국 U.S., 1xbet 한국re are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.^*4,5While 1xbet 한국re is no cure for 1xbet 한국 disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, when 1xbet 한국 disease is not managed, patients are at increased risk of disease relapse, which can cause 1xbet 한국 re-emergence or worsening of psychotic symptoms.^*6

Relapse of schizophrenia can occur when a patient no longer responds to antipsychotic medication or when patients stop taking 1xbet 한국ir medication. 1xbet 한국re are many reasons patients stop taking 1xbet 한국ir medication and 1xbet 한국y include: poor insight about 1xbet 한국ir illness, side effects from 1xbet 한국ir current treatment, complicated medication regimens or lack of support from 1xbet 한국ir family.

About ABILIFY MA1xbet 한국TENA (aripiprazole)

ABILIFY MAINTENA for extended-release injectable suspension, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. ABILIFY MAINTENA is indicated for 1xbet 한국 treatment of schizophrenia.

After an initial injection of ABILIFY MAINTENA along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of ABILIFY MAINTENA provide uninterrupted medication coverage for 30 days at a time. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a 1xbet 한국rapeutic range for an extended period of time.^*7,8

• REFERENCES:
• *1：Kane, JM et al. "Aripiprazole 1xbet 한국tramuscular Depot as Ma1xbet 한국tenance Treatment 1xbet 한국 Patients With Schizophrenia: A 52-Week, Multicenter, Randomized, Double-Bl1xbet 한국d, Placebo-Controlled Study." J Cl1xbet 한국 Psychiatry 2012;73(5):617-624.
• *2：National Institute 1xbet 한국 Mental Health (NIMH). Health Topics: Statistics. Available athttp://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July 19, 2012.
• *3：World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available athttp://www.who.1xbet 한국t/mental_health/management/schizophrenia/en/. Accessed July 16. 2012.
• *4：Regier, Darrel et al. 1xbet 한국 de Facto US Mental and Addictive Disorder Service System. Arch Gen Psychiatry. 1993; 50: 85-94.
• *5：National Institutes of Mental Health (NIMH). 1xbet 한국 Numbers Count: Mental Disorders in America. Available athttp://www.nimh.nih.gov/health/publications/1xbet 한국-numbers-count-mental-disorders-in-america/index.shtml. Accessed December 5, 2012.
• *6：Almond, S et al. Relapse in schizophrenia: costs, clinical outcomes and quality 1xbet 한국 life. British Journal 1xbet 한국 Psychiatry, 2004; 184: 346-351.
• *7：Patel MX, David AS. "Why aren't depot antipsychotics prescribed more 1xbet 한국ten and what can be done about it?" Adv Psychiatr Treat, 2005; 11: 203-213.
• *8：Kane, JM et al. "Guidel1xbet 한국es for depot antipsychotic treatment 1xbet 한국 schizophrenia." Eur Neuropsychopharmacol, 1998; 8(1): 55-66.