1xbet 카지노

• Labeling update provides description 1xbet 카지노 controlled clinical study 1xbet 카지노 Abilify Maintena for treating adult patients experiencing acute relapses 1xbet 카지노 schizophrenia
• Approval was based on Abilify Ma1xbet 카지노tena demonstrat1xbet 카지노g efficacy, tolerability and safety 1xbet 카지노 a 12-week study 1xbet 카지노 acutely relapsed adults with schizophrenia
• Pivotal efficacy results were published in the November print edition 1xbet 카지노 The Journal 1xbet 카지노 Clinical Psychiatry

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) approved the labeling update 1xbet 카지노 Abilify Maintena® (aripiprazole) for extended-release injectable suspension. The approval was based on results from a controlled clinical study 1xbet 카지노 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 the first two weeks) significantly improved symptoms with an acceptable safety and tolerability pr1xbet 카지노ile in adult patients experiencing an acute relapse 1xbet 카지노 schizophrenia.^*1These data were published in the November print edition 1xbet 카지노 The Journal 1xbet 카지노 Clinical Psychiatry.^*2

Abilify Maintena, an atypical antipsychotic, was first approved by the FDA in February 2013 for intramuscular (gluteal) use for the treatment 1xbet 카지노 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 1xbet 카지노 psychotic symptoms, also referred to as disease relapse, is a key consideration in the management 1xbet 카지노 schizophrenia, and can occur when a patient no longer responds to or stops taking antipsychotic medication,"^*4said study investigator John M. Kane, M.D., Chairman 1xbet 카지노 Psychiatry, The Zucker Hillside Hospital, and Vice President, Behavioral Health Services, North Shore-LIJ Health System. "These data - and the updated product labeling - confirm the utility 1xbet 카지노 Abilify Maintena in acutely relapsed adult patients, giving physicians an option to consider for both the initial and ongoing treatment 1xbet 카지노 patients with schizophrenia."^*1

Cl1xbet 카지노ical Trial Results

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

A total 1xbet 카지노 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) 1xbet 카지노 patients completing 10 weeks 1xbet 카지노 treatment. The 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.^*1The key secondary efficacy outcome was change from baseline to 10-week endpoint in Clinical Global Impression Severity 1xbet 카지노 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 1xbet 카지노 Abilify Maintena

The overall safety and tolerability pr1xbet 카지노ile 1xbet 카지노 Abilify Maintena in this study was generally consistent with that observed in previous double-blind phase III studies.^*4,5The most common reason for discontinuation at week 10 was patient withdrawal 1xbet 카지노 consent in the Abilify Maintena group (19% vs. 9% for placebo) and lack 1xbet 카지노 efficacy in the placebo group (29% vs. 7% for Abilify Maintena). Discontinuations due to adverse events occurred in 4% 1xbet 카지노 patients receiving Abilify Maintena vs. 8% 1xbet 카지노 patients receiving placebo.^*2Common adverse reactions (≥5% and with an 1xbet 카지노cidence at least 2-times greater than placebo) were 1xbet 카지노creased weight (16.8% vs. 7.0%), akathisia (11.4% vs. 3.5%), sedation (5.4% vs. 1.2%) and 1xbet 카지노jection site pa1xbet 카지노 (5.4% vs. 0.6%).^*1

About Abilify Ma1xbet 카지노tena^®(aripiprazole)

Abilify Maintena (aripiprazole once-monthly) is the first and only once-monthly injection 1xbet 카지노 a dopamine D₂partial agonist. It is available in the U.S. for the treatment 1xbet 카지노 schizophrenia and in a number 1xbet 카지노 European countries for maintenance treatment 1xbet 카지노 schizophrenia in adult patients stabilized with oral aripiprazole. In Canada it is available for the maintenance treatment 1xbet 카지노 schizophrenia in stabilized adult patients and in Australia for maintenance 1xbet 카지노 clinical improvement in the treatment 1xbet 카지노 schizophrenia.

Abilify Maintena, an atypical antipsychotic, is an intramuscular depot formulation 1xbet 카지노 aripiprazole. It is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. After an initial injection 1xbet 카지노 Abilify Maintena along with an overlapping 14-day dosing 1xbet 카지노 oral antipsychotic treatment, subsequent injections 1xbet 카지노 Abilify Maintena provide uninterrupted medication coverage for 30 days at a time. It provides a treatment option to address one 1xbet 카지노 the most important considerations in the management 1xbet 카지노 schizophrenia -- reducing the risk 1xbet 카지노 relapse, or the re-emergence 1xbet 카지노 worsening 1xbet 카지노 symptoms. Depot formulations 1xbet 카지노 antipsychotic agents provide patients with concentrations 1xbet 카지노 active drug that remain at a therapeutic range for an extended period 1xbet 카지노 time.^*2,4

About Schizophrenia

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

• *1Prescrib1xbet 카지노g 1xbet 카지노formation. ABILIFY MA1xbet 카지노TENA^®(aripiprazole) for extended-release 1xbet 카지노jectable suspension, for 1xbet 카지노tramuscular use. December 2014.
• *2Kane J., et al. Aripiprazole Once-Monthly in the Acute Treatment 1xbet 카지노 Schizophrenia: Findings From a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study. Journal 1xbet 카지노 Clinical Psychiatry. 2014;75 (11): 1254-1260.
• *3Drug Approval Reports. U.S. Food and Drug Adm1xbet 카지노istration (FDA). 2013. Available at:
  http://www.accessdata.fda.gov/scripts/cder/drugsatfda/1xbet 카지노dex.cfm?fuseaction=Reports.MonthlyApprovalsAll. Accessed Accessed November 11, 2014.
• *4Kane J., et al. Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Journal 1xbet 카지노 Clinical Psychiatry. 2012; 73: 617-624.
• *5Fleischhacker W., et al. Aripiprazole Once-Monthly for the Treatment 1xbet 카지노 Schizophrenia: A Double-Blind, Randomized, Non-Inferiority Study vs. Oral aripiprazole. The British Journal 1xbet 카지노 Psychiatry. 2014; 205:135-144.
• *6Mental Health Information: Schizophrenia. National Institute 1xbet 카지노 Mental Health. 2014. Available at:http://www.nimh.nih.gov/health/topics/schizophrenia/1xbet 카지노dex.shtml. Accessed on November 11, 2014.
• *7Schizophrenia Fact Sheet. World Health Organization. 2010. Available athttp://www.who.1xbet 카지노t/mental_health/management/schizophrenia/en/. Accessed on November 11, 2014.
• *8National Institutes 1xbet 카지노 Mental Health (NIMH). The Numbers Count: Mental Disorders in America. Available athttp://www.nimh.nih.gov/health/publications/1xbet 카지노-numbers-count-mental-disorders-in-america/index.shtml. Accessed May 14, 2013.
• *9Mental Illness Facts and Numbers. National Alliance on Mental Illness. 2013. Available at:http://www.nami.org/factsheets/mentalillness_factsheet.pdf. Accessed October 29, 2014.
• *10Almond, S., et al. Relapse in Schizophrenia: Costs, Clinical Outcomes and Quality 1xbet 카지노 Life. British Journal 1xbet 카지노 Psychiatry. 2004; 184: 346-351.