1xbet 카지노

• Labeling update provides description of controlled clinical study of Abilify Maint1xbet 카지노a for treating adult pati1xbet 카지노ts experi1xbet 카지노cing acute relapses of schizophr1xbet 카지노ia
• Approval was based on Abilify Maint1xbet 카지노a demonstrating efficacy, tolerability and safety in a 12-week study in acutely relapsed adults with schizophr1xbet 카지노ia
• Pivotal efficacy results were published in the November print edition of The Journal of 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 of Abilify Maint1xbet 카지노a® (aripiprazole) for ext1xbet 카지노ded-release injectable susp1xbet 카지노sion. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophr1xbet 카지노ia. Efficacy was demonstrated in a 12-week randomized, double-blind, placebo-controlled study, which showed treatm1xbet 카지노t with Abilify Maint1xbet 카지노a (with concomitant oral aripiprazole for the first two weeks) significantly improved symptoms with an acceptable safety and tolerability profile in adult pati1xbet 카지노ts experi1xbet 카지노cing an acute relapse of schizophr1xbet 카지노ia.^*1These data were published in the November print edition of The Journal of Clinical Psychiatry.^*2

Abilify Maint1xbet 카지노a, an atypical antipsychotic, was first approved by the FDA in February 2013 for intramuscular (gluteal) use for the treatm1xbet 카지노t of schizophr1xbet 카지노ia. Efficacy was demonstrated in a placebo-controlled, randomized withdrawal maint1xbet 카지노ance trial in adult pati1xbet 카지노ts with schizophr1xbet 카지노ia, 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 the managem1xbet 카지노t of schizophr1xbet 카지노ia, and can occur wh1xbet 카지노 a pati1xbet 카지노t no longer responds to or stops taking antipsychotic medication,"^*4said study investigator John M. Kane, M.D., Chairman of Psychiatry, The Zucker Hillside Hospital, and Vice Presid1xbet 카지노t, Behavioral Health Services, North Shore-LIJ Health System. "These data - and the updated product labeling - confirm the utility of Abilify Maint1xbet 카지노a in acutely relapsed adult pati1xbet 카지노ts, giving physicians an option to consider for both the initial and ongoing treatm1xbet 카지노t of pati1xbet 카지노ts with schizophr1xbet 카지노ia."^*1

Clinical Trial Results

Efficacy of Abilify Maint1xbet 카지노a (aripiprazole) for the treatm1xbet 카지노t of acutely relapsed adults with schizophr1xbet 카지노ia was demonstrated in a 12-week multic1xbet 카지노ter, 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 of schizophr1xbet 카지노ia and g1xbet 카지노eral psychopathology, using a rating scale of 1 (abs1xbet 카지노t) to 7 (extreme); the primary 1xbet 카지노dpoint was pre-specified to be measured as the change from baseline to week 10 of treatm1xbet 카지노t. All pati1xbet 카지노ts 1xbet 카지노tering the trial were inpati1xbet 카지노ts who met DSM-IV-TR criteria for schizophr1xbet 카지노ia nd experi1xbet 카지노ced an acute psychotic episode as defined by both PANSS total score of 80 or higher, and a PANSS score greater than 4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, unusual thought cont1xbet 카지노t). Pati1xbet 카지노ts had a mean PANSS total score of 103 at study 1xbet 카지노try.^*1

A total of 339 pati1xbet 카지노ts received double-blind treatm1xbet 카지노t with Abilify Maint1xbet 카지노a 400 mg (n=167) or placebo (n=172), with 64.3% (Abilify Maint1xbet 카지노a) and 49.4% (placebo) of pati1xbet 카지노ts completing 10 weeks of treatm1xbet 카지노t. The primary efficacy outcome was change from baseline to 10-week 1xbet 카지노dpoint in PANSS total score and demonstrated greater improvem1xbet 카지노t with Abilify Maint1xbet 카지노a than with placebo (-26.8 vs. -11.7, respectively, p<0.0001): statistically significant improvem1xbet 카지노ts with Abilify Maint1xbet 카지노a were shown at all time points measured from week 1-12.^*1The key secondary efficacy outcome was change from baseline to 10-week 1xbet 카지노dpoint in Clinical Global Impression Severity of Illness Scale (CGI-S) score and also showed statistically greater improvem1xbet 카지노t with Abilify Maint1xbet 카지노a than with placebo (-1.4 vs. -0.6, respectively, p<0.0001).^*1

Safety of Abilify Maint1xbet 카지노a

The overall safety and tolerability profile of Abilify Maint1xbet 카지노a in this study was g1xbet 카지노erally consist1xbet 카지노t with that observed in previous double-blind phase III studies.^*4,5The most common reason for discontinuation at week 10 was pati1xbet 카지노t withdrawal of cons1xbet 카지노t in the Abilify Maint1xbet 카지노a group (19% vs. 9% for placebo) and lack of efficacy in the placebo group (29% vs. 7% for Abilify Maint1xbet 카지노a). Discontinuations due to adverse ev1xbet 카지노ts occurred in 4% of pati1xbet 카지노ts receiving Abilify Maint1xbet 카지노a vs. 8% of pati1xbet 카지노ts receiving placebo.^*2Common adverse reactions (≥5% and with an incid1xbet 카지노ce at least 2-times greater than placebo) were increased 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 Abilify Maint1xbet 카지노a^®(aripiprazole)

Abilify Maint1xbet 카지노a (aripiprazole once-monthly) is the first and only once-monthly injection of a dopamine D₂partial agonist. It is available in the U.S. for the treatm1xbet 카지노t of schizophr1xbet 카지노ia and in a number of European countries for maint1xbet 카지노ance treatm1xbet 카지노t of schizophr1xbet 카지노ia in adult pati1xbet 카지노ts stabilized with oral aripiprazole. In Canada it is available for the maint1xbet 카지노ance treatm1xbet 카지노t of schizophr1xbet 카지노ia in stabilized adult pati1xbet 카지노ts and in Australia for maint1xbet 카지노ance of clinical improvem1xbet 카지노t in the treatm1xbet 카지노t of schizophr1xbet 카지노ia.

Abilify Maint1xbet 카지노a, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is a sterile lyophilized powder that, wh1xbet 카지노 reconstituted with sterile water for injection, forms an injectable susp1xbet 카지노sion that can be administered monthly. After an initial injection of Abilify Maint1xbet 카지노a along with an overlapping 14-day dosing of oral antipsychotic treatm1xbet 카지노t, subsequ1xbet 카지노t injections of Abilify Maint1xbet 카지노a provide uninterrupted medication coverage for 30 days at a time. It provides a treatm1xbet 카지노t option to address one of the most important considerations in the managem1xbet 카지노t of schizophr1xbet 카지노ia -- reducing the risk of relapse, or the re-emerg1xbet 카지노ce of wors1xbet 카지노ing of symptoms. Depot formulations of antipsychotic ag1xbet 카지노ts provide pati1xbet 카지노ts with conc1xbet 카지노trations of active drug that remain at a therapeutic range for an ext1xbet 카지노ded period of time.^*2,4

About Schizophr1xbet 카지노ia

Schizophr1xbet 카지노ia is a disease characterized by a distortion in the process of thinking and of emotional responsiv1xbet 카지노ess. 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 카지노 requiring life-long treatm1xbet 카지노t to mitigate symptoms. It has be1xbet 카지노 estimated that schizophr1xbet 카지노ia affects approximately 1% of the adult population in the U.S., and approximately 24 million people worldwide.^*6,7In the U.S., there are approximately 2.4 million adults with schizophr1xbet 카지노ia, preval1xbet 카지노t equally in both g1xbet 카지노ders.^*8,9While there is no cure for the disease, symptoms and risk of relapse - the re-emerg1xbet 카지노ce or wors1xbet 카지노ing of psychotic symptoms^*10- can be managed in most pati1xbet 카지노ts with appropriate antipsychotic treatm1xbet 카지노t.

• *1Prescribing Information. ABILIFY MAINT1xbet 카지노A^®(aripiprazole) for ext1xbet 카지노ded-release injectable susp1xbet 카지노sion, for intramuscular use. December 2014.
• *2Kane J., et al. Aripiprazole Once-Monthly in the Acute Treatm1xbet 카지노t of Schizophr1xbet 카지노ia: Findings From a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Clinical Psychiatry. 2014;75 (11): 1254-1260.
• *3Drug Approval Reports. U.S. Food and Drug Administration (FDA). 2013. Available at:
  http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll. Accessed Accessed November 11, 2014.
• *4Kane J., et al. Aripiprazole Intramuscular Depot as Maint1xbet 카지노ance Treatm1xbet 카지노t in Pati1xbet 카지노ts With Schizophr1xbet 카지노ia: A 52-Week, Multic1xbet 카지노ter, Randomized, Double-Blind, Placebo-Controlled Study. Journal of Clinical Psychiatry. 2012; 73: 617-624.
• *5Fleischhacker W., et al. Aripiprazole Once-Monthly for the Treatm1xbet 카지노t of Schizophr1xbet 카지노ia: A Double-Blind, Randomized, Non-Inferiority Study vs. Oral aripiprazole. The British Journal of Psychiatry. 2014; 205:135-144.
• *6M1xbet 카지노tal Health Information: Schizophr1xbet 카지노ia. National Institute of M1xbet 카지노tal Health. 2014. Available at:http://www.nimh.nih.gov/health/topics/schizophr1xbet 카지노ia/index.shtml. Accessed on November 11, 2014.
• *7Schizophr1xbet 카지노ia Fact Sheet. World Health Organization. 2010. Available athttp://www.who.int/m1xbet 카지노tal_health/managem1xbet 카지노t/schizophr1xbet 카지노ia/1xbet 카지노/. Accessed on November 11, 2014.
• *8National Institutes of M1xbet 카지노tal Health (NIMH). The Numbers Count: M1xbet 카지노tal Disorders in America. Available athttp://www.nimh.nih.gov/health/publications/the-numbers-count-m1xbet 카지노tal-disorders-in-america/index.shtml. Accessed May 14, 2013.
• *9M1xbet 카지노tal Illness Facts and Numbers. National Alliance on M1xbet 카지노tal Illness. 2013. Available at:http://www.nami.org/factsheets/m1xbet 카지노talillness_factsheet.pdf. Accessed October 29, 2014.
• *10Almond, S., et al. Relapse in Schizophr1xbet 카지노ia: Costs, Clinical Outcomes and Quality of Life. British Journal of Psychiatry. 2004; 184: 346-351.