FDA approves XEOMIN ®'s application for license for complementary biologics
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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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salivating is a common symptom in patients with neurological disorders including Parkinson's disease, amyotrophic lateral sclerosis, cerebral palsy or strokeThis symptom may occur due to difficulties in keeping saliva in the mouth, swallowing and controlling facial musclesrecently, the U.Sfdaapproved Merz's North Americancompany ®(incobotulinumtoxinA) for a supplementary biologic scounbar application (sBLA) to treat chronic salivating or excessive drooling in adult patients-related studies
the XEOMIN ® was approved based on a randomized, double-blind, placebo-controlled, multicenter, three-stagetrial(184 patients)The experiment reached two common major endpointsa statistically significant improvement was observed in the unstimulated saliva flow rate (uSFR) and the global change scale (GICS) compared to placebo using 100U incobotulinumtoxinA (the former p-0.004, the latter p-0.002)GICS is a common rating system used by clinicians to treat neurological disordersThe overall frequency of adverse events was similar between the placebo group and the treatment groupthis is the fourth neuropathy approved in the XEOMIN ®, thedrug (first approved by the FDA in 2010 for the treatment of patients with cervical muscle dystonia in adults, as well as eyelid spasms caused by Botox ® Botox, and upper limb spasms approved in 2015 for treatment in adult patients.)
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