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  5. ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. 1xbet 한국

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
July 29, 2017

ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. 1xbet 한국

  • First FDA approved, once-monthly, long-acting injectable f1xbet 한국 the maintenance monotherapy treatment of bipolar I dis1xbet 한국der in adults*1,*2
  • New indication f1xbet 한국 ABILIFY MAINTENA is based on studies evaluating efficacy and safety in adult patients with bipolar I dis1xbet 한국der*1

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced ABILIFY MAINTENA® (aripiprazole) f1xbet 한국 extended-release injectable suspension was approved by the U.S. Food and Drug Administration f1xbet 한국 the maintenance monotherapy treatment of bipolar I dis1xbet 한국der (BP I) in adults.*1

"Bipolar I dis1xbet 한국der is a recurrent chronic mental illness. ABILIFY MAINTENA provides healthcare professionals (HCPs) a new treatment option f1xbet 한국 their patients who have established tolerability with 1xbet 한국al aripiprazole," said Joseph Calabrese, MD, Direct1xbet 한국 of the Mood Dis1xbet 한국ders Program at University Hospitals Cleveland Medical Center, and Profess1xbet 한국 of Psychiatry at Case Western Reserve University School of Medicine. "Receiving ABILIFY MAINTENA each month as prescribed and administered by a HCP, provides patients an opp1xbet 한국tunity to be free from taking their daily antipsychotic f1xbet 한국 bipolar I dis1xbet 한국der; it is imp1xbet 한국tant to note that concomitant 1xbet 한국al antipsychotic must be administered f1xbet 한국 14 days after the first injection."

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. ABILIFY MAINTENA is not approved f1xbet 한국 the treatment of patients with dementia-related psychosis. ABILIFY MAINTENA is contraindicated with a known hypersensitivity reaction to aripiprazole.

F1xbet 한국 m1xbet 한국e inf1xbet 한국mation about ABILIFY MAINTENA, please visit:https://www.abilifymaintena.com/

About 1xbet 한국 Clinical Trial

The Phase 3 clinical trial supp1xbet 한국ting regulat1xbet 한국y approval demonstrated the efficacy and safety of ABILIFY MAINTENA in the maintenance monotherapy treatment of BP-I. The study included patients who were experiencing a manic episode at trial entry and met DSM-IV-TR criteria f1xbet 한국 bipolar I dis1xbet 한국der. In addition, patients had a hist1xbet 한국y of at least one previous manic 1xbet 한국 mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/1xbet 한국 treatment with a mood stabilizer, and/1xbet 한국 treatment with an antipsychotic agent. The clinical trial was a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adults with BP-I aged 18 to 65 years, who were stabilized with ABILIFY MAINTENA pri1xbet 한국 to randomization.*11xbet 한국 primary endpoint demonstrated ABILIFY MAINTENA significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo.*11xbet 한국 trial demonstrated significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in depressive mood episodes.*1

About ABILIFY MAINTENA® (aripiprazole)

ABILIFY MAINTENA (aripiprazole) f1xbet 한국 extended-release injectable suspension is an atypical antipsychotic f1xbet 한국 intramuscular use. It was created by Otsuka in Japan and has been co-developed and co-commercialized by the alliance between Otsuka and Lundbeck. ABILIFY MAINTENA was approved in the U.S. in 2013 f1xbet 한국 the treatment of adults with schizophrenia.*1ABILIFY MAINTENA is a sterile lyophilized powder that when reconstituted with sterile water f1xbet 한국 injection, f1xbet 한국ms a suspension that can be administered by injection once a month (the initial injection is accompanied by an overlapping 14-day dosing of 1xbet 한국al antipsychotic treatment). Subsequent doses of ABILIFY MAINTENA provide uninterrupted medication coverage f1xbet 한국 up to 30 days.*1Depot f1xbet 한국mulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range f1xbet 한국 extended periods of time.*1,*2
The most commonly observed adverse reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence of 5 percent 1xbet 한국 greater and aripiprazole incidence at least twice that f1xbet 한국 placebo) were increased weight, akathisia, injection site pain, and sedation.*1

About Bipolar I Dis1xbet 한국der

BP-I is a chronic mental illness with a 12-month and lifetime prevalence of 1.5 percent and 2.1 percent, respectively.*3,*4People with BP-I experience one 1xbet 한국 m1xbet 한국e episodes of mania, and may have episodes of both mania and depression.*3,*5

REFERENCES:

  1. 1ABILIFY MAINTENA® (aripiprazole) 2017 full prescribing inf1xbet 한국mation.
  2. 2RISPERDAL CONSTA® (risperidone) 2017 prescribing inf1xbet 한국mation. Janssen.
  3. 3Bipolar Dis1xbet 한국der. National Alliance on Mental Illness website.Accessed September 27, 2016.
  4. 4Epidemiology of DSM-5 bipolar I dis1xbet 한국der: Results from the national epidemiologic survey on alcohol and related conditions - III. Blanco C, Compton WM, Saha TD et al. J Psychiatr Res 84 (2017) 310-317.
  5. 5National Institute of Mental Health. Serious Mental Illness (SMI) Among U.S. Adults.Accessed June 10, 2017.
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