FDA approves Sympazan oral membrane for treatment of LGS-related seizures in patients 2 years and older
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, Aquestive StoveS announced that the U.SFDAapproved Sympazan (clobazam, chlorbagen) oral membrane for patients 2 years and older to treat seizures associated with Lennox-Gastaut syndrome (LGS)thecompany's, which is planned to bring Sympazan to market in the near futurethis approval, making Sympazan the first and only oral membrane agent approved by the FDA to treat LGS-related seizuresPreviously, chlorba-occupy was listed under the brand name Onfi and was available in two dosage forms, both oral tablets and oral suspensionabout LGS
LGS is a severe and incurable type of epilepsy that begins in early childhood and is characterized by multiple types of seizures and intellectual disabilitiesLGS patients often have difficulty swallowing pills and large volumes due to physical limitations, behavioral or cognitive effects, which can lead to uncertainty and inconsistency in the amount of the drug given, increasing the burden of care, especially for patients who may be resistant to treatmentsince thewas approved by the FDA in 2011, chlorbaoccupy tablets and oral fluids (brand name: Onfi) have been a trusted complementary therapy for the LGS patient populationIn a randomized, double-blind, placebo-controlled Phase III study of 238 LGS patients, chlorba tablets significantly reduced the frequency of seizure falls (involving falls) by 41% (low dose) to 68% (high dose) and placebo by 12% (all doses vsplacebo, p 0.05)Several pharmacokinetic studies conductedhave shown that Sympazan oral membranes are bioequivalent to chlorpyrifos and have similar safety characteristics Sympazan oral membraneis is berry-flavoured and has 3 dose sizes (5mg, 10mg, 20mg) to meet the needs of a wide range of LGS patients and caregivers
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