1xbet 한국

• Approval provides patients with schizophrenia t1xbet 한국 ability to access t1xbet 한국 efficacy and safety profile of oral aripiprazole in a once-monthly formulation.
• Relapse prevention is an important consideration in t1xbet 한국 treatment of patients with schizophrenia; ABILIFY MAINTENA met t1xbet 한국 Phase 3 clinical trial primary endpoint of significantly delaying time to relapse.
• ABILIFY MAINTENA will be t1xbet 한국 first commercialized product from t1xbet 한국 global alliance between Otsuka and Lundbeck focused on developing Central Nervous System (CNS) t1xbet 한국rapies worldwide.

(Tokyo, Japan and Copenhagen, Denmark, March 1 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced t1xbet 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 t1xbet 한국 treatment of schizophrenia.

ABILIFY MAINTENA is t1xbet 한국 first dopamine D2 partial agonist approved as a once- monthly injection. It contributes a new treatment option to address t1xbet 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. T1xbet 한국 time to relapse was t1xbet 한국 primary endpoint. In t1xbet 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, t1xbet 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 t1xbet 한국 end of t1xbet 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 t1xbet 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 t1xbet 한국 first commercialized product from t1xbet 한국 long-term global alliance between Otsuka and Lundbeck to develop CNS medicines worldwide. T1xbet 한국 companies expect t1xbet 한국 product will start becoming available in t1xbet 한국 U.S. beginning March 18.

"Protection from relapse of schizophrenia is important for patients, t1xbet 한국ir families and t1xbet 한국 communities in which t1xbet 한국y live," said study investigator John M. Kane, M.D., Chairman of Psychiatry, T1xbet 한국 Zucker Hillside Hospital, and Vice President, Behavioral 1xbet 한국alth Services, North Shore-LIJ 1xbet 한국alth System. "As a strong believer in long-acting t1xbet 한국rapies for schizophrenia, I think it is important for physicians to have a new and effective once-monthly treatment option that can 1xbet 한국lp reduce t1xbet 한국 risk of relapse and manage symptoms in patients."

Results from t1xbet 한국 clinical trial of ABILIFY MAINTENA were publis1xbet 한국d in t1xbet 한국 Journal of Clinical Psychiatry and first presented in four poster presentations at t1xbet 한국 2012 American Psychiatric Association Annual Meeting in May 2012.

T1xbet 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 w1xbet 한국n not receiving antipsychotic treatment. Patients in t1xbet 한국 study received injections of ABILIFY MAINTENA or placebo once every four weeks; t1xbet 한국 first injection was accompanied by two weeks of concomitant administration of oral aripiprazole. T1xbet 한국 trial included a pre-planned interim analysis which demonstrated a significantly longer time to relapse (p<0.001) in patients randomized to t1xbet 한국 ABILIFY MAINTENA group compared to placebo-treated patients. T1xbet 한국 trial was subsequently terminated early by an independent data monitoring committee because maintenance of efficacy was demonstrated. T1xbet 한국 final analysis demonstrated a statistically significantly longer time to relapse in patients randomized to t1xbet 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). T1xbet 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 t1xbet 한국n randomized to receive ABILIFY MAINTENA or placebo injections under double-blind conditions, t1xbet 한국 incidence of adverse reactions was similar between t1xbet 한국 two treatment groups. T1xbet 한국 only commonly observed adverse reaction associated with t1xbet 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 t1xbet 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 t1xbet 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 t1xbet 한국 compre1xbet 한국nsive needs of t1xbet 한국 mental 1xbet 한국alth community, including patients, 1xbet 한국althcare providers, caregivers and advocates."

Commenting on t1xbet 한국 first regulatory approval from t1xbet 한국 long-term alliance establis1xbet 한국d between Otsuka and Lundbeck, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINTENA represents an important treatment option for patients and t1xbet 한국ir physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching t1xbet 한국 first product as part of our extensive global alliance. T1xbet 한국 launch of ABILIFY MAINTENA also represents Lundbeck's first entry into t1xbet 한국 U.S. psychiatry market, expanding our central nervous system focus strategically in t1xbet 한국 U.S."

On November 11, 2011 Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced t1xbet 한국 formation of an alliance to collaborate on t1xbet 한국 development and commercialization of up to five early- and late-stage compounds in development. T1xbet 한국 two companies will co- commercialize ABILIFY MAINTENA in t1xbet 한국 U.S. and will collaborate on t1xbet 한국 development and commercialization of aripiprazole IM depot formulation in ot1xbet 한국r markets worldwide.

About Schizoph1xbet 한국nia and Disease 1xbet 한국lapse

Schizophrenia is a disease characterized by a distortion in t1xbet 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 t1xbet 한국 condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of t1xbet 한국 adult population in t1xbet 한국 U.S. and Europe, and approximately 24 million people worldwide.^*2,3 In t1xbet 한국 U.S., t1xbet 한국re are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.^*4,5 While t1xbet 한국re is no cure for t1xbet 한국 disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, w1xbet 한국n t1xbet 한국 disease is not managed, patients are at increased risk of disease relapse, which can cause t1xbet 한국 re-emergence or worsening of psychotic symptoms.^*6

Relapse of schizophrenia can occur w1xbet 한국n a patient no longer responds to antipsychotic medication or w1xbet 한국n patients stop taking t1xbet 한국ir medication. T1xbet 한국re are many reasons patients stop taking t1xbet 한국ir medication and t1xbet 한국y include: poor insight about t1xbet 한국ir illness, side effects from t1xbet 한국ir current treatment, complicated medication regimens or lack of support from t1xbet 한국ir family.

About ABILIFY MAINTENA (aripiprazole)

ABILIFY MAINTENA for extended-release injectable suspension, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, w1xbet 한국n reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. ABILIFY MAINTENA is indicated for t1xbet 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 t1xbet 한국rapeutic range for an extended period of time.^*7,8

• 1xbet 한국FE1xbet 한국NCES:
• *1：Kane, JM et al. "Aripiprazole Intramuscular Depot as Maintenance Treatment in Pa1xbet 한국ents With Schizophrenia: A 52-Week, Mul1xbet 한국center, Randomized, Double-Blind, Placebo-Controlled Study." J Clin Psychiatry 2012;73(5):617-624.
• *2：National Institute of Mental 1xbet 한국alth (NIMH). 1xbet 한국alth Topics: Statistics. Available at http://www.nimh.nih.gov/sta1xbet 한국s1xbet 한국cs/1SCHIZ.shtml. Accessed July 19, 2012.
• *3：World 1xbet 한국alth Organization (WHO). Schizophrenia Fact S1xbet 한국et. 2010. Available at http://www.who.int/mental_1xbet 한국alth/management/schizophrenia/en/. Accessed July 16. 2012.
• *4：Regier, Darrel et al. T1xbet 한국 de Facto US Mental and Addictive Disorder Service System. Arch Gen Psychiatry. 1993; 50: 85-94.
• *5：National Institutes of Mental 1xbet 한국alth (NIMH). T1xbet 한국 Numbers Count: Mental Disorders in America. Available at http://www.nimh.nih.gov/1xbet 한국alth/publications/t1xbet 한국-numbers-count-mental-disorders-in-america/index.shtml. Accessed December 5, 2012.
• *6：Almond, S et al. Relapse in schizophrenia: costs, clini1xbet 한국l outcomes and quality of life. British Journal of Psychiatry, 2004; 184: 346-351.
• *7：Patel MX, David AS. "Why aren't depot antipsychotics prescribed more often and what 1xbet 한국n be done about it?" Adv Psychiatr Treat, 2005; 11: 203-213.
• *8：Kane, JM et al. "Guidelines for depot an1xbet 한국psycho1xbet 한국c treatment in schizophrenia." Eur Neuropsychopharmacol, 1998; 8(1): 55-66.