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日本药企卫材(Eisai)近日宣布,在美国推出新一代癫痫药物Fycompa(perampanel)口服混悬液,作为一种辅助疗法,用于12岁及以上癫痫患者部分发作性癫痫(有或无继发性全身性癫痫发作)和原发性全面强直阵挛(PGTC)癫痫发作的治疗。Fycompa口服混悬液剂型与Fycompa片剂剂型具有生物等效性和可互换性,将为吞咽片剂可能存在困难或更倾向液体制剂的癫痫患者提供一种新的选择。在美国,Fycompa口服混悬液于今年4月底获FDA批准,该药的获批是基于一项生物等效性研究的数据。该研究在健康受试
Japanese pharmaceutical company Eisai recently announced the introduction of oral suspension of the new generation of epilepsy drug Fycompa (perampanel) in the United States as an adjuvant therapy for partial seizures in patients with epilepsy aged 12 years and older (with or without subsequent Paroxysmal generalized seizures) and primary generalized tonic clonic (PGTC) seizures. Fycompa oral suspension formulations are bioequivalent and interchangeable with Fycompa Tablets formulations and will provide a new option for patients with epilepsy who may have difficulty swallowing tablets or prefer liquid formulations. In the United States, Fycompa’s oral suspension was approved by the FDA at the end of April this year. The approval was based on data from a bioequivalence study. The study is in a healthy trial