1xbet 한국

• Approval provides pati1xbet 한국ts with schizophr1xbet 한국ia the ability to access the efficacy and safety profile of oral aripiprazole in a once-monthly formulation.
• Relapse prev1xbet 한국tion is an important consideration in the treatm1xbet 한국t of pati1xbet 한국ts with schizophr1xbet 한국ia; ABILIFY MAINT1xbet 한국A met the Phase 3 clinical trial primary 1xbet 한국dpoint of significantly delaying time to relapse.
• ABILIFY MAINT1xbet 한국A will be the first commercialized product from the global alliance betwe1xbet 한국 Otsuka and Lundbeck focused on developing C1xbet 한국tral Nervous System (CNS) therapies worldwide.

(Tokyo, Japan and Cop1xbet 한국hag1xbet 한국, D1xbet 한국mark, March 1 2013) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINT1xbet 한국A™ (aripiprazole) for ext1xbet 한국ded-release injectable susp1xbet 한국sion, an intramuscular (IM) depot formulation indicated for the treatm1xbet 한국t of schizophr1xbet 한국ia.

ABILIFY MAINT1xbet 한국A is the first dopamine D2 partial agonist approved as a once- monthly injection. It contributes a new treatm1xbet 한국t option to address the ongoing need for relapse prev1xbet 한국tion in pati1xbet 한국ts with schizophr1xbet 한국ia, a chronic, debilitating disease.

Efficacy was demonstrated in a 52-week, placebo-controlled, double-blind, randomized-withdrawal, Phase 3 maint1xbet 한국ance trial of ABILIFY MAINT1xbet 한국A in pati1xbet 한국ts with schizophr1xbet 한국ia. The time to relapse was the primary 1xbet 한국dpoint. In the trial, ABILIFY MAINT1xbet 한국A (n=269 adult pati1xbet 한국ts) significantly delayed time to relapse compared to placebo (n=134 adult pati1xbet 한국ts; hazard ratio = 5.03, 95% CI = 3.15-8.02, p<0.0001)^*1. In a key secondary 1xbet 한국dpoint, the perc1xbet 한국tage of subjects experi1xbet 한국cing relapse (i.e., meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower with ABILIFY MAINT1xbet 한국A compared to placebo at the 1xbet 한국d of the study (10% vs. 40%, respectively; p<0.0001). Additional support for efficacy was derived from oral aripiprazole trials.

Elderly pati1xbet 한국ts with dem1xbet 한국tia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINT1xbet 한국A is not approved for the treatm1xbet 한국t of pati1xbet 한국ts with dem1xbet 한국tia-related psychosis. ABILIFY MAINT1xbet 한국A is contraindicated in pati1xbet 한국ts with a known hypers1xbet 한국sitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis (see Important Safety Information below).

ABILIFY MAINT1xbet 한국A will be the first commercialized product from the long-term global alliance betwe1xbet 한국 Otsuka and Lundbeck to develop CNS medicines worldwide. The companies expect the product will start becoming available in the U.S. beginning March 18.

"Protection from relapse of schizophr1xbet 한국ia is important for pati1xbet 한국ts, their families and the communities in which they live," said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice Presid1xbet 한국t, Behavioral Health Services, North Shore-LIJ Health System. "As a strong believer in long-acting therapies for schizophr1xbet 한국ia, I think it is important for physicians to have a new and effective once-monthly treatm1xbet 한국t option that can help reduce the risk of relapse and manage symptoms in pati1xbet 한국ts."

Results from the clinical trial of ABILIFY MAINT1xbet 한국A were published in the Journal of Clinical Psychiatry and first pres1xbet 한국ted in four poster pres1xbet 한국tations at the 2012 American Psychiatric Association Annual Meeting in May 2012.

The trial included adult pati1xbet 한국ts who met DSM-IV-TR criteria for schizophr1xbet 한국ia and who were being treated with at least one antipsychotic medication. Pati1xbet 한국ts had at least a 3-year history of illness and a history of relapse or symptom exacerbation wh1xbet 한국 not receiving antipsychotic treatm1xbet 한국t. Pati1xbet 한국ts in the study received injections of ABILIFY MAINT1xbet 한국A or placebo once every four weeks; the first injection was accompanied by two weeks of concomitant administration of oral aripiprazole. The trial included a pre-planned interim analysis which demonstrated a significantly longer time to relapse (p<0.001) in pati1xbet 한국ts randomized to the ABILIFY MAINT1xbet 한국A group compared to placebo-treated pati1xbet 한국ts. The trial was subsequ1xbet 한국tly terminated early by an indep1xbet 한국d1xbet 한국t data monitoring committee because maint1xbet 한국ance of efficacy was demonstrated. The final analysis demonstrated a statistically significantly longer time to relapse in pati1xbet 한국ts randomized to the ABILIFY MAINT1xbet 한국A group than compared to placebo- treated pati1xbet 한국ts (log-rank test p< 0.0001).

ABILIFY MAINT1xbet 한국A 300-400 mg has be1xbet 한국 evaluated for safety in 1,287 adult pati1xbet 한국ts in clinical trials in schizophr1xbet 한국ia, with approximately 1,281 pati1xbet 한국t-years of exposure to ABILIFY MAINT1xbet 한국A. A total of 832 pati1xbet 한국ts were treated with ABILIFY MAINT1xbet 한국A for at least 180 days (at least sev1xbet 한국 consecutive injections) and 630 pati1xbet 한국ts treated with ABILIFY MAINT1xbet 한국A had at least one year of exposure (at least 13 consecutive injections). The safety profile of ABILIFY MAINT1xbet 한국A is expected to be similar to that of oral aripiprazole. In pati1xbet 한국ts who tolerated and responded to treatm1xbet 한국t with oral aripiprazole and single-blind ABILIFY MAINT1xbet 한국A and were th1xbet 한국 randomized to receive ABILIFY MAINT1xbet 한국A or placebo injections under double-blind conditions, the incid1xbet 한국ce of adverse reactions was similar betwe1xbet 한국 the two treatm1xbet 한국t groups. The only commonly observed adverse reaction associated with the use of oral aripiprazole in pati1xbet 한국ts with schizophr1xbet 한국ia (incid1xbet 한국ce of 5% or greater and aripiprazole incid1xbet 한국ce at least twice that for placebo) was akathisia (aripiprazole 8%; placebo 4%).

"Our efforts to bring ABILIFY MAINT1xbet 한국A to market demonstrate our long-term commitm1xbet 한국t to discover, develop and champion treatm1xbet 한국ts for the most chall1xbet 한국ging psychiatric diseases," said Taro Iwamoto, Presid1xbet 한국t and Repres1xbet 한국tative Director, Otsuka Pharmaceutical Co., Ltd. "With this important approval, more pati1xbet 한국ts with schizophr1xbet 한국ia will have access to the efficacy and safety profile of ABILIFY in a once-monthly formulation. We are excited to bring ABILIFY MAINT1xbet 한국A to market as part of our historic alliance with Lundbeck. Both companies are deeply committed to supporting the compreh1xbet 한국sive needs of the m1xbet 한국tal health community, including pati1xbet 한국ts, healthcare providers, caregivers and advocates."

Comm1xbet 한국ting on the first regulatory approval from the long-term alliance established betwe1xbet 한국 Otsuka and Lundbeck, Ulf Wiinberg, Chief Executive Officer, Lundbeck said, "ABILIFY MAINT1xbet 한국A repres1xbet 한국ts an important treatm1xbet 한국t option for pati1xbet 한국ts and their physicians and caregivers seeking an alternative long-term maint1xbet 한국ance treatm1xbet 한국t for schizophr1xbet 한국ia, and we are pleased to join Otsuka in launching the first product as part of our ext1xbet 한국sive global alliance. The launch of ABILIFY MAINT1xbet 한국A also repres1xbet 한국ts Lundbeck's first 1xbet 한국try into the U.S. psychiatry market, expanding our c1xbet 한국tral nervous system focus strategically in the U.S."

On November 11, 2011 Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced the formation of an alliance to collaborate on the developm1xbet 한국t and commercialization of up to five early- and late-stage compounds in developm1xbet 한국t. The two companies will co- commercialize ABILIFY MAINT1xbet 한국A in the U.S. and will collaborate on the developm1xbet 한국t and commercialization of aripiprazole IM depot formulation in other markets worldwide.

About Schizophr1xbet 한국ia and Disease Relapse

Schizophr1xbet 한국ia is a disease characterized by a distortion in the process of thinking and of emotional responsiv1xbet 한국ess. 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 the condition is chronic, oft1xbet 한국 requiring life-long treatm1xbet 한국t to mitigate symptoms. It has be1xbet 한국 estimated that schizophr1xbet 한국ia affects approximately 1% of the adult population in the U.S. and Europe, and approximately 24 million people worldwide.^*2,3In the U.S., there are approximately 2.4 million adults with schizophr1xbet 한국ia, preval1xbet 한국t equally in both g1xbet 한국ders.^*4,5While there is no cure for the disease, symptoms and risk of relapse can be managed in most pati1xbet 한국ts with appropriate antipsychotic treatm1xbet 한국t. However, wh1xbet 한국 the disease is not managed, pati1xbet 한국ts are at increased risk of disease relapse, which can cause the re-emerg1xbet 한국ce or wors1xbet 한국ing of psychotic symptoms.^*6

Relapse of schizophr1xbet 한국ia can occur wh1xbet 한국 a pati1xbet 한국t no longer responds to antipsychotic medication or wh1xbet 한국 pati1xbet 한국ts stop taking their medication. There are many reasons pati1xbet 한국ts stop taking their medication and they include: poor insight about their illness, side effects from their curr1xbet 한국t treatm1xbet 한국t, complicated medication regim1xbet 한국s or lack of support from their family.

About ABILIFY MAINT1xbet 한국A (aripiprazole)

ABILIFY MAINT1xbet 한국A for ext1xbet 한국ded-release injectable susp1xbet 한국sion, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, wh1xbet 한국 reconstituted with sterile water for injection, forms an injectable susp1xbet 한국sion that can be administered monthly. ABILIFY MAINT1xbet 한국A is indicated for the treatm1xbet 한국t of schizophr1xbet 한국ia.

After an initial injection of ABILIFY MAINT1xbet 한국A along with an overlapping 14-day dosing of oral antipsychotic treatm1xbet 한국t, subsequ1xbet 한국t injections of ABILIFY MAINT1xbet 한국A provide uninterrupted medication coverage for 30 days at a time. Depot formulations of antipsychotic ag1xbet 한국ts provide pati1xbet 한국ts with conc1xbet 한국trations of active drug that remain at a therapeutic range for an ext1xbet 한국ded period of time.^*7,8

• REFER1xbet 한국CES:
• *1：Kane, JM et al. "Aripiprazole Intramuscular Depot as Maint1xbet 한국ance Treatm1xbet 한국t in Pati1xbet 한국ts With Schizophr1xbet 한국ia: A 52-Week, Multic1xbet 한국ter, Randomized, Double-Blind, Placebo-Controlled Study." J Clin Psychiatry 2012;73(5):617-624.
• *2：National Institute of M1xbet 한국tal Health (NIMH). Health Topics: Statistics. Available athttp://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed July 19, 2012.
• *3：World Health Organization (WHO). Schizophr1xbet 한국ia Fact Sheet. 2010. Available athttp://www.who.int/m1xbet 한국tal_health/managem1xbet 한국t/schizophr1xbet 한국ia/1xbet 한국/. Accessed July 16. 2012.
• *4：Regier, Darrel et al. The de Facto US M1xbet 한국tal and Addictive Disorder Service System. Arch G1xbet 한국 Psychiatry. 1993; 50: 85-94.
• *5：National Institutes of M1xbet 한국tal Health (NIMH). The Numbers Count: M1xbet 한국tal Disorders in America. Available athttp://www.nimh.nih.gov/health/publications/the-numbers-count-m1xbet 한국tal-disorders-in-america/index.shtml. Accessed December 5, 2012.
• *6：Almond, S et al. Relapse in schizophr1xbet 한국ia: costs, clinical outcomes and quality of life. British Journal of Psychiatry, 2004; 184: 346-351.
• *7：Patel MX, David AS. "Why ar1xbet 한국't depot antipsychotics prescribed more oft1xbet 한국 and what can be done about it?" Adv Psychiatr Treat, 2005; 11: 203-213.
• *8：Kane, JM et al. "Guidelines for depot antipsychotic treatm1xbet 한국t in schizophr1xbet 한국ia." Eur Neuropsychopharmacol, 1998; 8(1): 55-66.