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【drug-news】FDA批准Invega 治疗精神分裂症
The Food and Drug Administration (FDA) today approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia. Paliperidone is a new molecular entity, which means this medication contains an active substance that has never before been approved for marketing in any form in the United States. Paliperidone is the principal active metabolite of risperidone, a marketed drug for treating schizophrenia.
"Schizophrenia can be a devastating illness requiring lifelong medication and professional counseling," said Douglas Throckmorton, MD, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval adds to the treatment options for patients with this condition."
Schizophrenia is a chronic, disabling mental disorder that affects more than two million Americans. Symptoms include hallucinations, delusions, disordered thinking, movement disorders, social withdrawal and cognitive deficits (e.g., difficulty with perception, memory or abstract thinking that interferes with one's ability to learn; impaired judgment, inattentiveness, impulsiveness or impairment of speech and language).
The effectiveness of Invega in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled trials conducted in North America, Europe and Asia. The 1665 participating adults were evaluated for the full array of signs and symptoms of schizophrenia. In the three studies using doses ranging from three milligrams (mg) to 15 mg a day, the effectiveness of Invega at relieving symptoms of schizophrenia was superior to the placebo treatment. The recommended dose range for Invega is three mg to 12 mg a day.
Among the commonly reported adverse events were restlessness, extrapyramidal symptoms (movement disorders), rapid heart beat and sleepiness. Invega is a member of a class of drugs called atypical antipsychotics that have an increased rate of death compared with placebo in elderly patients with dementia-related psychosis. Invega is not approved for dementia-related psychosis.
The effectiveness of Invega has not been evaluated in placebo-controlled trials for longer than six weeks, and patients who use the drug for extended periods should be periodically reevaluated by a physician.
Invega is manufactured by ALZA Corp. in Mountain View, CA. for Janssen, L.P. in Titusville, NJ.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01534.html 本人已认领此文，若48小时未给出翻译，有其他战友自由领取。 FDA Approves New Drug for Schizophrenia
FDA批准Invega 治疗精神分裂症
The Food and Drug Administration (FDA) today approved Invega (paliperidone帕利瑞酮) extended-release tablets for the treatment of schizophrenia. Paliperidone is a new molecular entity, which means this medication contains an active substance that has never before been approved for marketing in any form in the United States. Paliperidone is the principal active metabolite of risperidone, a marketed drug for treating schizophrenia.
(美国)食品及药物管理局今天批准Invega帕利瑞酮进入临床治疗精神分裂症，帕利瑞酮是一种新的分子药物，这种药物中包含一种在美国市场上从来没有批准过的活性物质。帕利瑞酮是利培酮主要的活性代谢物，利培酮是已经上市的治疗精神分裂症的药物。
"Schizophrenia can be a devastating illness requiring lifelong medication and professional counseling," said Douglas Throckmorton, MD, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval adds to the treatment options for patients with this condition."
FDA药物评价和研究中心主任Douglas Throckmorton, MD说道“精神分裂症可能是一个需要终生用药和终生作心理职业咨询的极具破坏性的疾病，今天批准帕利瑞酮上市使得精神分裂症的病人有了更多的治疗选择”
Schizophrenia is a chronic, disabling mental disorder that affects more than two million Americans. Symptoms include hallucinations, delusions, disordered thinking, movement disorders, social withdrawal and cognitive deficits (e.g., difficulty with perception, memory or abstract thinking that interferes with one's ability to learn; impaired judgment, inattentiveness, impulsiveness or impairment of speech and language).
精神分裂症是一个影响了超过两百万美国人的慢性、失用性精神障碍。精神分裂症的症状包括幻觉、妄想、思维紊乱、行动障碍、社交退缩（社交恐惧）和认知障碍（联想障碍，思维散漫没法专心学习、判断力下降、注意力减退、冲动或失语、丧失语言能力等等）
The effectiveness of Invega in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled trials conducted in North America, Europe and Asia. The 1665 participating adults were evaluated for the full array of signs and symptoms of schizophrenia. In the three studies using doses ranging from three milligrams (mg) to 15 mg a day, the effectiveness of Invega at relieving symptoms of schizophrenia was superior to the placebo treatment. The recommended dose range for Invega is three mg to 12 mg a day.
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作者:admin@医学,生命科学 2011-03-30 17:30
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