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【drug-news】FDA批准Saphris用于治疗精神分裂症和双
The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function.
“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”
The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.
Bipolar I disorder is a chronic, severe, and recurrent psychiatric disorder that causes alternating periods of depression and high, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
Saphris is in a class of drugs called atypical antipsychotics. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis (a brain disorder that lessens the ability to remember, think, and reason). Saphris is not approved for these patients.
The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.
The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder.
The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were the inability to sit still or remain motionless (akathisia), decreased oral sensitivity (oral hypoesthesia) and drowsiness (somnolence).
The most common adverse reactions reported by patients in clinical trials using Saphris to treat bipolar disorder were drowsiness, dizziness, movement disorders other than akathisia and weight increase.
Saphris is manufactured by Schering-Plough, Kenilworth, N.J.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm177401.htm 自我认领了。 初译：
FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder
FDA批准Saphris用于治疗精神分裂症和双极I型精神病
The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function.
（8月14日），美国食品药品监督管理局（FDA）已批准Saphris片（通用名asenapine）用于治疗成人精神分裂症（一种慢性、严重性并且能使人丧失能力的脑部疾病），以及用于治疗成人双极I型精神病（一种严重的精神疾病，可引起人的情绪、精力和身体功能的改变）。
“Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.”
FDA药物评估和研究中心的精神药品部门主任Thomas Laughren博士表示，“像精神分裂和躁郁症之类的精神疾病会给患者及其家庭带来极大的伤害，并需要终身治疗。而有效的药物则有助于这些精神病患者过上比较独立的生活。”
The most common symptoms of schizophrenia include hearing voices, or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid. These thoughts may be terrifying and can cause fearfulness, withdrawal, agitation or violence.
精神分裂症的最常见症状包括听见说话声、看见实际并不存在的东西、有错误的信念（如相信别人正在控制自己的想法、琢磨自己的心思或正在密谋伤害自己），以及具有不正当的怀疑或偏执。这些想法可能会使患者处于恐惧中，从而引起害怕、不交际、焦虑甚至暴力行为。
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作者:admin@医学,生命科学 2010-12-09 17:11
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