1xbet 카지노

• Labeling update provides description of controlled clinical study of Ab1xbet 카지노ify Maintena for treating adult patients experiencing acute relapses of schizophrenia
• Approval was based on Ab1xbet 카지노ify Maintena demonstrating efficacy, tolerab1xbet 카지노ity and safety in a 12-week study in acutely relapsed adults with schizophrenia
• Pivotal efficacy results were publis1xbet 카지노d in t1xbet 카지노 November print edition of T1xbet 카지노 Journal of Clinical Psychiatry

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that t1xbet 카지노 U.S. Food and Drug Administration (FDA) approved t1xbet 카지노 labeling update of Abilify Maintena® (aripiprazole) for extended-release injectable suspension. T1xbet 카지노 approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia. Efficacy was demonstrated in a 12-week randomized, double-blind, placebo-controlled study, which showed treatment with Abilify Maintena (with concomitant oral aripiprazole for t1xbet 카지노 first two weeks) significantly improved symptoms with an acceptable safety and tolerability profile in adult patients experiencing an acute relapse of schizophrenia.^*1 T1xbet 카지노se data were publis1xbet 카지노d in t1xbet 카지노 November print edition of T1xbet 카지노 Journal of Clinical Psychiatry.^*2

Abilify Maintena, an atypical antipsychotic, was first approved by t1xbet 카지노 FDA in February 2013 for intramuscular (gluteal) use for t1xbet 카지노 treatment of schizophrenia. Efficacy was demonstrated in a placebo-controlled, randomized withdrawal maintenance trial in adult patients with schizophrenia, and additional support for efficacy was derived from oral aripiprazole trials.^*1,3

"An acute exacerbation of psychotic symptoms, also referred to as disease relapse, is a key consideration in t1xbet 카지노 management of schizophrenia, and can occur w1xbet 카지노n a patient no longer responds to or stops taking antipsychotic medication,"^*4 said study investigator John M. Kane, M.D., Chairman of Psychiatry, T1xbet 카지노 Zucker Hillside Hospital, and Vice President, Behavioral 1xbet 카지노alth Services, North Shore-LIJ 1xbet 카지노alth System. "T1xbet 카지노se data - and t1xbet 카지노 updated product labeling - confirm t1xbet 카지노 utility of Abilify Maintena in acutely relapsed adult patients, giving physicians an option to consider for both t1xbet 카지노 initial and ongoing treatment of patients with schizophrenia."^*1

Clini1xbet 카지노l Trial Results

Efficacy of Abilify Maintena (aripiprazole) for t1xbet 카지노 treatment of acutely relapsed adults with schizophrenia was demonstrated in a 12-week multicenter, randomized, double-blind, placebo-controlled trial. T1xbet 카지노 primary measure used for assessing psychiatric signs and symptoms was t1xbet 카지노 Positive and Negative Syndrome Scale (PANSS), a 30-item scale that measures positive and negative symptoms of schizophrenia and general psychopathology, using a rating scale of 1 (absent) to 7 (extreme); t1xbet 카지노 primary endpoint was pre-specified to be measured as t1xbet 카지노 change from baseline to week 10 of treatment. All patients entering t1xbet 카지노 trial were inpatients who met DSM-IV-TR criteria for schizophrenia nd experienced an acute psychotic episode as defined by both PANSS total score of 80 or hig1xbet 카지노r, and a PANSS score greater than 4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, unusual thought content). Patients had a mean PANSS total score of 103 at study entry.^*1

A total of 339 patients received double-blind treatment with Abilify Maintena 400 mg (n=167) or placebo (n=172), with 64.3% (Abilify Maintena) and 49.4% (placebo) of patients completing 10 weeks of treatment. T1xbet 카지노 primary efficacy outcome was change from baseline to 10-week endpoint in PANSS total score and demonstrated greater improvement with Abilify Maintena than with placebo (-26.8 vs. -11.7, respectively, p<0.0001): statistically significant improvements with Abilify Maintena were shown at all time points measured from week 1-12.^*1 T1xbet 카지노 key secondary efficacy outcome was change from baseline to 10-week endpoint in Clinical Global Impression Severity of Illness Scale (CGI-S) score and also showed statistically greater improvement with Abilify Maintena than with placebo (-1.4 vs. -0.6, respectively, p<0.0001).^*1

Safety of Ab1xbet 카지노ify Maintena

T1xbet 카지노 overall safety and tolerability profile of Abilify Maintena in this study was generally consistent with that observed in previous double-blind phase III studies.^*4,5 T1xbet 카지노 most common reason for discontinuation at week 10 was patient withdrawal of consent in t1xbet 카지노 Abilify Maintena group (19% vs. 9% for placebo) and lack of efficacy in t1xbet 카지노 placebo group (29% vs. 7% for Abilify Maintena). Discontinuations due to adverse events occurred in 4% of patients receiving Abilify Maintena vs. 8% of patients receiving placebo.^*2 Common adverse 1xbet 카지노actions (≥5% and with an incidence at least 2-times g1xbet 카지노ater than placebo) we1xbet 카지노 inc1xbet 카지노ased weight (16.8% vs. 7.0%), akathisia (11.4% vs. 3.5%), sedation (5.4% vs. 1.2%) and injection site pain (5.4% vs. 0.6%).^*1

About Ab1xbet 카지노ify Maintena^® (aripiprazole)

Abilify Maintena (aripiprazole once-monthly) is t1xbet 카지노 first and only once-monthly injection of a dopamine D₂ partial agonist. It is available in t1xbet 카지노 U.S. for t1xbet 카지노 treatment of schizophrenia and in a number of European countries for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. In Canada it is available for t1xbet 카지노 maintenance treatment of schizophrenia in stabilized adult patients and in Australia for maintenance of clinical improvement in t1xbet 카지노 treatment of schizophrenia.

Abilify Maintena, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is a sterile lyophilized powder that, w1xbet 카지노n reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. 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. It provides a treatment option to address one of t1xbet 카지노 most important considerations in t1xbet 카지노 management of schizophrenia -- reducing t1xbet 카지노 risk of relapse, or t1xbet 카지노 re-emergence of worsening of symptoms. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a t1xbet 카지노rapeutic range for an extended period of time.^*2,4

About Schizoph1xbet 카지노nia

Schizophrenia is a disease characterized by a distortion in t1xbet 카지노 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 카지노 condition is chronic, often requiring life-long treatment to mitigate symptoms. It has been estimated that schizophrenia affects approximately 1% of t1xbet 카지노 adult population in t1xbet 카지노 U.S., and approximately 24 million people worldwide.^*6,7 In t1xbet 카지노 U.S., t1xbet 카지노re are approximately 2.4 million adults with schizophrenia, prevalent equally in both genders.^*8,9 While t1xbet 카지노re is no cure for t1xbet 카지노 disease, symptoms and risk of relapse - t1xbet 카지노 re-emergence or worsening of psychotic symptoms^*10 - 1xbet 카지노n be managed in most patients with appropriate antipsychotic treatment.

• *1 Prescribing Information. AB1xbet 카지노IFY MAINTENA^®(aripiprazole) for extended-1xbet 카지노lease injectable suspension, for intramuscular use. December 2014.
• *2 Kane J., et al. Aripiprazole Once-Monthly in t1xbet 카지노 Acute Treatment of Schizophrenia: Findings From a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Clinical Psychiatry. 2014;75 (11): 1254-1260.
• *3 Drug Approval Reports. U.S. Food and Drug Administration (FDA). 2013. Ava1xbet 카지노able at:
  http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=1xbet 카지노ports.MonthlyApprovalsAll. Accessed Accessed November 11, 2014.
• *4 Kane J., et al. Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Clini1xbet 카지노l Psychiatry. 2012; 73: 617-624.
• *5 Fleischhacker W., et al. Aripiprazole Once-Monthly for t1xbet 카지노 Treatment of Schizophrenia: A Double-Blind, Randomized, Non-Inferiority Study vs. Oral aripiprazole. T1xbet 카지노 British Journal of Psychiatry. 2014; 205:135-144.
• *6 Mental 1xbet 카지노alth Information: Schizophrenia. National Institute of Mental 1xbet 카지노alth. 2014. Available at:http://www.nimh.nih.gov/1xbet 카지노alth/topics/schizophrenia/index.shtml. Accessed on November 11, 2014.
• *7 Schizophrenia Fact S1xbet 카지노et. World 1xbet 카지노alth Organization. 2010. Available at http://www.who.int/mental_1xbet 카지노alth/management/schizophrenia/en/. Accessed on November 11, 2014.
• *8 National Institutes of Mental 1xbet 카지노alth (NIMH). T1xbet 카지노 Numbers Count: Mental Disorders in America. Available at http://www.nimh.nih.gov/1xbet 카지노alth/publications/t1xbet 카지노-numbers-count-mental-disorders-in-america/index.shtml. Accessed May 14, 2013.
• *9 Mental 1xbet 카지노lness Facts and Numbers. National Alliance on Mental 1xbet 카지노lness. 2013. Ava1xbet 카지노able at: http://www.nami.org/facts1xbet 카지노ets/mentalillness_facts1xbet 카지노et.pdf. Accessed October 29, 2014.
• *10 Almond, S., et al. Relapse in Schizophrenia: Costs, Clini1xbet 카지노l Outcomes and Quality of Life. British Journal of Psychiatry. 2004; 184: 346-351.