美国食品及药物管理局（FDA）12月20日批准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。 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做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”。 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）。 帕利瑞酮的疗效对于精神分裂症急性期治疗的效果是通过3个6周的研究确定的，在北美，欧洲和亚洲进行了安慰剂对照实验。1665个成年人经过一系列精神分裂症的症状和体征评价入选。在3个研究中，帕利瑞酮的用量为3mg每天到15mg每天不等，帕利瑞酮比安慰剂更能缓解精神分裂症的症状，推荐的帕利瑞酮的用量是每天3mg到12mg。 在报道的副作用中常见的是烦躁不安，椎体外系症状（运动障碍），心跳加快和嗜睡。帕利瑞酮是不典型的安定药物的一种，它会使患有老年痴呆的精神病患者的死亡率增加，帕利瑞酮是不能用于有痴呆的精神病人的。 目前还没有对Invega（帕利瑞酮）与安慰剂组进行对照实验超过6周，使用该药超过6周的患者要定期随诊内科医生。 NVEGA® (paliperidone) extended-release tablets are used for the treatment of schizophrenia. IMPORTANT SAFETY INFORMATION FOR INVEGA Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone) is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with INVEGA and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS. One risk of INVEGA is that it may change your heart rhythm. This effect is potentially serious, and you should talk to your doctor about any current or past heart problems. Some medications interact with INVEGA. Please inform your healthcare professional of any medications or supplements that you are taking. Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped. High blood sugar and diabetes have been reported with INVEGA and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with INVEGA. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor. INVEGA and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown. People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their healthcare professional before taking INVEGA. Some people taking INVEGA may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced or it may go away over time. INVEGA may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. Avoid alcohol while on INVEGA. INVEGA should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures. Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional. Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking INVEGA. Caution should be exercised when INVEGA is administered to a nursing woman. INVEGA may affect alertness and motor skills; use caution until the effect of INVEGA is known. INVEGA may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm. INVEGA should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released. The most common side effects that occurred with INVEGA were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).