药品信息:
据美国媒体最新资讯，美国Supernus Pharmaceuticals生物制药公司此前向美国食品和药物监管局提交了关于癫痫症新药Trokendi XR的上市申请书，经过一系列的药效审查之后，药监局表示批准该药物的上市申请，该消息一经传出，Supernus Pharmaceuticals生物制药公司的股价迅速飙涨，增幅高达164%。
据Supernus Pharmaceuticals生物制药公司表示，药监局在对癫痫症新药Trokendi XR的审查过程中，进行了药效以及药物安全度的评估，该药物是强生生物制药公司广为使用的癫痫药物Topamax的延长释放型药物，但是强生制药公司的这种癫痫药物专利保护已经到期，市场上也已经出现了数种等效仿制药。
托吡酯(Topiramate)是妥泰(Topamax)等效仿制药物的名称，目前托吡酯(Topiramate)市场中在售的系列中仅仅有速释型药物，而且在癫痫病的治疗过程中充当辅助治疗药物，同时该仿制药物还可以用于治疗偏头痛。
妥泰别名托吡酯，对各类癫痫发作均有效，该药物对肌阵挛，婴儿痉挛也有效。2011年4月14日美国强生生物制药公司宣布，由于接到4起在药品中发现难闻异味的报告，强生制药公司宣布在市场上召回5.7万瓶抗癫痫药妥泰。
Supernus生物制药公司表示，由于该药物的治疗群体较为特殊，因此药监局在审查过程中提出需要赋予该药物市场独家销售的权力。
目前市场上的癫痫病药物种类较多，美国迈兰生物制药公司(Mylan Pharmaceuticals)已经在市场上开售Keppra XR等效仿制药，Keppra XR药物是UCB SA研发的癫痫药物。
癫痫(epilepsy)是大脑神经元突发性异常放电，导致短暂的大脑功能障碍的一种慢性疾病。该种病症的特征是突然和一过性症状，由于异常放电的神经元在大脑中的部位不同，因此该种病症有多种多样的表现，该病症常会导致各种神经以及身体疾病。
Trokendi XR™ (topiramate) extended-release capsules is a prescription medicine used to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in people 10 years of age and older, and with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 6 years and older.
IMPORTANT SAFETY INFORMATION
Do not take Trokendi XR if
you have recently consumed or plan to consume alcohol (ie, within 6 hours prior to and 6 hours after Trokendi XR use)
you have metabolic acidosis and are also taking metformin (eg, Glucophage®)
Trokendi XR can cause serious side effects, including: Eye problems. Serious eye problems include sudden decrease in vision with or without eye pain or redness, a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). Decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Increased levels of acid in the blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm the unborn child of pregnant patients. High levels of ammonia in the blood. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. Blood ammonia levels have been shown to rise when Trokendi XR is taken with a medicine called valproic acid (eg, DEPAKENE® and DEPAKOTE®). Kidney stones. Drink plenty of fluids when taking Trokendi XR to decrease your chances of getting kidney stones. Low body temperature. Taking Trokendi XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma. Effects on thinking and alertness. Trokendi XR may affect how you think, and can cause confusion and problems with concentration, attention, memory, or speech. Trokendi XR may cause depression or mood problems, tiredness, and sleepiness. Dizziness or loss of muscle coordination. The most common side effects include tingling of the arms and legs (paresthesia), loss of appetite, nausea, a change in the way foods taste, diarrhea, weight loss, nervousness, and upper respiratory tract infection. These are not all the possible side effects of Trokendi XR. For more information, ask your healthcare provider or pharmacist.
Like other antiepileptic drugs, Trokendi XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Trokendi XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying; have attempted to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, trouble sleeping (insomnia), or new or worsening irritability; feel or act more aggressive, angry, or violent; act on dangerous impulses; have an extreme increase in activity and talking (mania); or experience other unusual changes in behavior or mood.
Before taking Trokendi XR, tell your healthcare provider about any other medical conditions, including if you have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or plan to become pregnant; or if you are breastfeeding. Trokendi XR passes into your breast milk. It is not known if the Trokendi XR that passes into breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Trokendi XR.
Trokendi XR can harm your unborn baby. If you take Trokendi XR during pregnancy, your baby has a higher risk for the birth defects cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
Tell your healthcare provider about any other medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Trokendi XR and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take metformin (eg, Glucophage); valproic acid (eg, DEPAKENE or DEPAKOTE); any medicines that impair or decrease your thinking, concentration, or muscle coordination; or birth control pills. Trokendi XR may make your birth control pills less effective.
Do not stop Trokendi XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Trokendi XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Trokendi XR slowly.
Do not drive a car or operate heavy machinery until you know how Trokendi XR affects you. Trokendi XR can slow your thinking and motor skills, and may affect vision. |
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