1xbet 한국 Pharmaceutical Co., Ltd.
Pharmaceuticals
July 29, 2017
ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. FDA for Maintenance Monotherapy Treatment 1xbet 한국 Bipolar I Disorder
- First FDA approved, once-monthly, long-acting injectable for the maintenance monotherapy treatment 1xbet 한국 bipolar I disorder in adults*1,*2
- New indication 1xbet 한국 ABILIFY MAINTENA is based on studies evaluating efficacy and safety in adult patients with bipolar I disorder*1
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension was approved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment 1xbet 한국 bipolar I disorder (BP I) in adults.*1
"Bipolar I disorder is a recurrent chronic mental illness. ABILIFY MAINTENA provides healthcare pr1xbet 한국essionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripiprazole," said Joseph Calabrese, MD, Director 1xbet 한국 the Mood Disorders Program at University Hospitals Cleveland Medical Center, and Pr1xbet 한국essor 1xbet 한국 Psychiatry at Case Western Reserve University School 1xbet 한국 Medicine. "Receiving ABILIFY MAINTENA each month as prescribed and administered by a HCP, provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder; it is important to note that concomitant oral antipsychotic must be administered for 14 days after the first injection."
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk 1xbet 한국 death. ABILIFY MAINTENA is not approved for the treatment 1xbet 한국 patients with dementia-related psychosis. ABILIFY MAINTENA is contraindicated with a known hypersensitivity reaction to aripiprazole.
1xbet 한국 more in1xbet 한국mation about ABILIFY MAINTENA, please visit:https://www.1xbet 한국maintena.com/
About 1xbet 한국 Clinical Trial
The Phase 3 clinical trial supporting regulatory approval demonstrated the efficacy and safety 1xbet 한국 ABILIFY MAINTENA in the maintenance monotherapy treatment 1xbet 한국 BP-I. The study included patients who were experiencing a manic episode at trial entry and met DSM-IV-TR criteria for bipolar I disorder. In addition, patients had a history 1xbet 한국 at least one previous manic or mixed episode with manic symptoms 1xbet 한국 sufficient severity to require one 1xbet 한국 the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or 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 prior to randomization.*1The primary endpoint demonstrated ABILIFY MAINTENA significantly delayed time to recurrence 1xbet 한국 any mood episode during a 52-week treatment study compared with placebo.*1The trial demonstrated significant differences between treatment groups in delaying time to recurrence 1xbet 한국 both manic and mixed episodes but no substantial difference in depressive mood episodes.*1
About 1xbet 한국 MAINTENA® (aripiprazole)
ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension is an atypical antipsychotic for 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 for the treatment 1xbet 한국 adults with schizophrenia.*1ABILIFY MAINTENA is a sterile lyophilized powder that when reconstituted with sterile water for injection, forms a suspension that can be administered by injection once a month (the initial injection is accompanied by an overlapping 14-day dosing 1xbet 한국 oral antipsychotic treatment). Subsequent doses 1xbet 한국 ABILIFY MAINTENA provide uninterrupted medication coverage for up to 30 days.*1Depot formulations 1xbet 한국 antipsychotic agents provide patients with concentrations 1xbet 한국 active drug that remain at a therapeutic range for extended periods 1xbet 한국 time.*1,*2
The most commonly observed adverse reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence 1xbet 한국 5 percent or greater and aripiprazole incidence at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation.*1
About Bipolar I Disorder
BP-I is a chronic mental illness with a 12-month and lifetime prevalence 1xbet 한국 1.5 percent and 2.1 percent, respectively.*3,*4People with BP-I experience one or more episodes 1xbet 한국 mania, and may have episodes 1xbet 한국 both mania and depression.*3,*5
REFERENCES:
- 1ABILIFY MAINTENA® (aripiprazole) 2017 full prescribing in1xbet 한국mation.
- 2RISPERDAL CONSTA® (risperidone) 2017 prescribing in1xbet 한국mation. Janssen.
- 3Bipolar Disorder. National Alliance on Mental Illness website.Accessed September 27, 2016.
- 4Epidemiology 1xbet 한국 DSM-5 bipolar I disorder: 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.
- 5National Institute 1xbet 한국 Mental Health. Serious Mental Illness (SMI) Among U.S. Adults.Accessed June 10, 2017.
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