美国FDA批准Horizant缓释片治疗不宁腿综合征.pptxVIP

2025/07/20FDAApprovalofHorizantforRestlessLegsSyndrome(RLS)Reporter:

CONTENTSCatalogue01OverviewofHorizantApproval02HorizantsClinicalTrialsandEfficacy03Dosage,Administration,andSideEffects

OverviewofHorizantApproval01

FDAAnnouncementDetailsIntroductionofHorizantHorizant,anFDA-approvedmedication,isspecificallydesignedtotreatmoderate-to-severeRestlessLegsSyndrome(RLS)symptoms.ApprovalProcessOverviewTheFDAapprovalprocessforHorizantinvolvedrigorousclinicaltrialsandathoroughreviewofsafetyandefficacydata.

FDAAnnouncementDetailsKeyApprovalMilestonesKeymilestonesintheapprovalprocessincludedtheinitialsubmissionoftheNewDrugApplication(NDA)andsubsequentresponsestoFDAqueries.Post-MarketSurveillancePost-marketsurveillanceplanswereestablishedtomonitorthelong-termsafetyandeffectivenessofHorizantinthegeneralpopulation.

HorizantsActiveIngredientandMechanism01ActiveIngredient:GabapentinEnacarbilHorizantcontainsgabapentinenacarbil,aprodrugofgabapentin,whichisusedtotreatmoderate-to-severeRLS.02MechanismofActionGabapentinenacarbilisconvertedtogabapentininthebody,whichaffectscertainnervesandchemicalsinthebraintoreduceRLSsymptoms.

HorizantsActiveIngredientandMechanismFDAApprovalMilestonesHorizantwasapprovedbytheFDAin2011afterclinicaltrialsdemonstrateditsefficacyandsafetyintreatingRLS.

HorizantsClinicalTrialsandEfficacy02

TrialDesignandDurationRandomizedControlledTrialsConductedrandomizedcontrolledtrialstoevaluateHorizantseffectivenessintreatingRLS,ensuringunbiasedresultsthroughrandomassignmentofparticipants.Double-BlindStudyImplementedadouble-blindstudydesigntopreventbias,whereneithertheparticipantsnortheresearchersknewwhoreceivedthetreatmentorplacebo.

TrialDesignandDurationLong-TermEfficacyAssessmentAssessedthelong-termefficacyofHorizantbyfollowingpatientso