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These dual mechanisms make it effective for seizure suppression and migraine prophylaxis.","oneSentence":"Qudexy XR is an extended-release formulation of topiramate that enhances GABAergic inhibition and blocks sodium channels in the central nervous system to reduce neuronal excitability.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:03:26.545Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Epilepsy (seizure prophylaxis)"},{"name":"Migraine prophylaxis"}]},"trialDetails":[{"nctId":"NCT04621929","phase":"PHASE3","title":"Phentermine/Topiramate for Uric Acid Stones","status":"COMPLETED","sponsor":"University of Florida","startDate":"2021-03-31","conditions":"Obesity, Uric Acid Stones, Type 2 Diabetes Mellitus in Obese","enrollment":19},{"nctId":"NCT05756764","phase":"","title":"Anti-obesity Pharmacotherapy and Inflammation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Louisiana State University Health Sciences Center in New Orleans","startDate":"2023-06-01","conditions":"Obesity","enrollment":30},{"nctId":"NCT04748601","phase":"PHASE4","title":"Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old","status":"RECRUITING","sponsor":"Upsher-Smith Laboratories","startDate":"2021-02-19","conditions":"Migraine Disorders","enrollment":132}],"_emaApprovals":[],"_faersSignals":[{"count":24,"reaction":"DIZZINESS"},{"count":22,"reaction":"DRUG INEFFECTIVE"},{"count":22,"reaction":"NAUSEA"},{"count":21,"reaction":"FEELING ABNORMAL"},{"count":19,"reaction":"SEIZURE"},{"count":18,"reaction":"HEADACHE"},{"count":17,"reaction":"FATIGUE"},{"count":17,"reaction":"SOMNOLENCE"},{"count":16,"reaction":"PARAESTHESIA"},{"count":14,"reaction":"MEMORY IMPAIRMENT"}],"_approvalHistory":[{"date":"20150616","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20140311","type":"ORIG","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20240328","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20221202","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20220204","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20200214","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20170329","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20170329","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20150330","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20260306","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20250312","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20210218","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"},{"date":"20190221","type":"SUPPL","sponsor":"UPSHER SMITH LABS","applicationNumber":"NDA205122"}],"publicationCount":13,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Qudexy XR","genericName":"Qudexy XR","companyName":"Upsher-Smith Laboratories","companyId":"upsher-smith-laboratories","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Qudexy XR is a small molecule medication used to study various conditions, including Migraine Disorders, Obesity, Uric Acid Stones, Type 2 Diabetes Mellitus in Obese, and Pre-Diabetes. It has been evaluated in clinical trials for the prevention of migraine in children 6 to 11 years old.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-03-11T00:00:00.000Z","mah":"UPSHER SMITH LABS","brand_name_local":"QUDEXY XR","application_number":"NDA205122"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}