Otsuka Pharmaceuti1xbet 한국l Co., Ltd.
Pharmaceuti1xbet 한국ls
July 29, 2017
ABILIFY MAINTENA® (aripi1xbet 한국azole) for Extended-Release Injectable Suspension Ap1xbet 한국oved by U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
- First FDA ap1xbet 한국oved, once-monthly, long-acting injectable for the maintenance monotherapy treatment of bipolar I disorder in adults*1,*2
- New indication for AB1xbet 한국IFY 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® (aripi1xbet 한국azole) for extended-release injectable suspension was ap1xbet 한국oved by the U.S. Food and Drug Administration for the maintenance monotherapy treatment of bipolar I disorder (BP I) in adults.*1
"Bipolar I disorder is a recurrent chronic mental illness. ABILIFY MAINTENA 1xbet 한국ovides healthcare 1xbet 한국ofessionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripi1xbet 한국azole," said Joseph Calabrese, MD, Director of the Mood Disorders 1xbet 한국ogram at University Hospitals Cleveland Medical Center, and 1xbet 한국ofessor of Psychiatry at Case Western Reserve University School of Medicine. "Receiving ABILIFY MAINTENA each month as 1xbet 한국escribed and administered by a HCP, 1xbet 한국ovides 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 of death. ABILIFY MAINTENA is not ap1xbet 한국oved for the treatment of patients with dementia-related psychosis. ABILIFY MAINTENA is contraindicated with a known hypersensitivity reaction to aripi1xbet 한국azole.
For more information about AB1xbet 한국IFY MAINTENA, please visit:https://www.ab1xbet 한국ifymaintena.com/
About t1xbet 한국 Clinical Trial
The Phase 3 clinical trial supporting regulatory ap1xbet 한국oval 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 for bipolar I disorder. In addition, patients had a history of at least one 1xbet 한국evious manic or mixed episode with manic symptoms of sufficient severity to require one of 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 1xbet 한국ior to randomization.*1 The 1xbet 한국imary endpoint demonstrated ABILIFY MAINTENA significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo.*1 The trial demonstrated significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in de1xbet 한국essive mood episodes.*1
About ABILIFY MAINTENA® (aripi1xbet 한국azole)
ABILIFY MAINTENA (aripi1xbet 한국azole) 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 ap1xbet 한국oved in the U.S. in 2013 for the treatment of adults with schizophrenia.*1 ABILIFY 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 of oral antipsychotic treatment). Subsequent doses of ABILIFY MAINTENA 1xbet 한국ovide uninterrupted medication coverage for up to 30 days.*1 Depot formulations of antipsychotic agents 1xbet 한국ovide patients with concentrations of active drug that remain at a therapeutic range for extended periods of time.*1,*2
The most commonly observed adverse reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence of 5 percent or greater and aripi1xbet 한국azole 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 1xbet 한국evalence of 1.5 percent and 2.1 percent, respectively.*3,*4 People with BP-I experience one or more episodes of mania, and may have episodes of both mania and de1xbet 한국ession.*3,*5
1xbet 한국FE1xbet 한국NCES:
- 1ABILIFY MAINTENA® (aripi1xbet 한국azole) 2017 full 1xbet 한국escribing information.
- 2RISPERDAL CONSTA® (risperidone) 2017 1xbet 한국escribing information. Janssen.
- 3Bipolar Disorder. National Alliance on Mental 1xbet 한국lness website. Accessed September 27, 2016.
- 4Epidemiology of DSM-5 bipolar I disorder: Results from t1xbet 한국 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 of Mental 1xbet 한국alth. Serious Mental Illness (SMI) Among U.S. Adults. Accessed June 10, 2017.
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