FDA批准Keppra治疗青少年肌阵挛性癫痫症 比利时UCB制药公司的Keppra作为辅助药物治疗青少年肌阵挛性癫痫症已获FDA批准，这是该药首次通过美国批准治疗这种最常见的癫痫症类型。   依据一项双盲随机安慰剂控制III期临床试验，试验期间，患者使用Keppra治疗之后15.1%的人未出现肌阵挛性癫痫症状，而安慰剂对照组中只有3.4%的人未发病。 UCB公司公布Keppra在2006年上半年的销售额达3.65亿欧元，新适应症的批准将会进一步增加该药的销售量。本月初，Keppra也刚在欧洲获准作为刚确诊局部发作性癫痫病患者的单用疗法。 癫痫症是大脑中的化学物质谷氨酸盐引发神经细胞出现毫无控制的活动，造成患者意识停滞或丧失的一种病症。神经学家普遍认为，癫痫导致大脑中异常的星型胶质细胞也就是反应性星型胶质细胞增多。正常的星型胶质细胞维持大脑正常的化学环境，而当这些细胞膨胀、体积变大后，就无法发挥这种“管家”的作用。 New Keppra XR™ Dosage Strength Offers Simplified Treatment Option for People Living With Partial-Onset Seizures ATLANTA (April 10, 2009) /PRNewswire/ — Once-daily Keppra XR™ (levetiracetam) extended-release tablets are now available in a new dosage strength—750 mg—enabling doctors to simplify patients' treatment plans by decreasing the number of tablets they take each day. According to studies published in Epilepsy & Behavior and Neurology, patients are more likely to adhere to their medication regimen when it is taken once daily, and therefore may be more likely to reach the goal of epilepsy therapy—seizure freedom with minimal side effects. Keppra XR™, from UCB, The Epilepsy Company™, was approved last year as an add-on therapy for partial-onset seizures in patients who are 16 years of age and older with epilepsy. Keppra XR™ is the only extended-release formulation of levetiracetam and cannot be substituted with generic levetiracetam, immediate-release levetiracetam or any other antiepileptic medication at the pharmacy counter. Keppra XR™ was approved by the U.S. Food and Drug Administration (FDA) based on data from an international clinical study of 158 epilepsy patients with partial-onset seizures who added 1,000 mg of Keppra XR™ or placebo to their other epilepsy medications once daily. The study consisted of an 8-week baseline period followed by a 12-week treatment period. The study showed that 10.1 percent of Keppra XR™ patients experienced complete partial-onset seizure freedom vs. 1.3 percent in the placebo group over the treatment period. Keppra XR™ patients experienced a 46.1 median percent reduction in weekly partial-onset seizure frequency versus 33.4 percent in the placebo group. Keppra XR™ is also available in 500 mg tablet strength. Data presented at last year's American Epilepsy Society meeting demonstrated that taking two 750 mg levetiracetam extended-release tablets is the same as taking three 500 mg extended-release tablets. Treatment with Keppra XR™ should be initiated with a dose of 1,000 mg once daily. The daily dosage may be adjusted in increments of 1,000 mg every two weeks, to a maximum recommended dose of 3,000 mg per day. Keppra XR™ Important Safety Information Keppra XR™ extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy. Keppra XR™ causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR™ in combination with other AEDs were somnolence and irritability. The adverse reactions that may be seen in patients receiving Keppra XR™ are expected to be similar to those seen in patients receiving immediate-release Keppra® (levetiracetam) tablets. Keppra® immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra® in combination with other AEDs were somnolence, asthenia, infection, and dizziness. Keppra XR™ should be gradually withdrawn to minimize the potential of increased seizure frequency. Dosing must be individualized according to the patient's renal function status. In patients with end-stage renal disease on dialysis, it is recommended that immediate-release Keppra® be used instead of Keppra XR™. Please see Keppra.com for Keppra® immediate-release tablets full prescribing information. For full prescribing information, please see www.KeppraXR.com. In order to ensure patient access to this valuable medication in the U.S., UCB is initiating a co-pay support program. For more information, contact U.S. UCB Medical Information at 1-866-822-0068 (press 9). About Epilepsy Epilepsy is a chronic neurological disorder affecting approximately three million people in the U.S.–making it more common than multiple sclerosis and Parkinson's disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes. Less than half of patients (47 percent) will attain seizure control with their first AED, and more than 30 percent will continue to experience seizures despite trying two or more AEDs. This highlights the ongoing need for the development of new AEDs. For more information about epilepsy, visit www.epilepsyfoundation.org, www.epilepsy.com, or www.epilepsyadvocate.com. About UCB UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB achieved revenue of 3.6 billion Euro in 2008. UCB is listed on Euronext Brussels (symbol: UCB). UCB U.S. headquarters is based in Atlanta. FDA批准UCB癫痫症Keppra静脉注射剂 UCB癫痫症治疗药Keppra静脉注射剂获得了FDA的批准，它是近期在美国获准的唯一一种含口服剂和注射剂的抗痫药。 Keppra用作局部发作性癫痫症成人患者的辅助治疗药。之前，它已具备片剂和口服液两种剂型，刚获准的注射剂将在癫痫症急性发作时使用。 Keppra已成为UCB最热销的药物，而它的注射剂将进一步推动其销量。 KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor. INDICATIONS KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. DOSAGE AND ADMINISTRATION KEPPRA is indicated a s adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Partial Onset Seizures Adults 16 Years And Older In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see Clinical Studies), a consistent increase in response with increased dose has not been shown. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit. Pediatric Patients Ages 4 To < 16 Years Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered. KEPPRA is given orally with or without food. HOW SUPPLIED KEPPRA 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "ucb 250" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474- 594-40). KEPPRA 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "ucb 500" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-595-40). KEPPRA 750 mg tablets are orange, oblong-shaped, scored, film-coated tablets debossed with "ucb 750" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-596-40). KEPPRA 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with “ucb 1000” on one side. They are supplied in white HDPE bottles containing 60 tablets (NDC 50474-597-66). KEPPRA 100 mg/mL oral solution is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. white HDPE bottles (NDC 50474-001-48). Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].