{"id":"lamotrigine-novel-formulation","safety":{"commonSideEffects":[{"rate":null,"effect":"Rash (including Stevens-Johnson syndrome risk)"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Ataxia"},{"rate":null,"effect":"Diplopia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lamotrigine is an anticonvulsant that stabilizes neuronal membranes by blocking sodium channels and reducing the release of the excitatory neurotransmitter glutamate. This novel formulation likely aims to improve bioavailability, reduce dosing frequency, or enhance tolerability compared to standard lamotrigine formulations. The mechanism remains consistent with the established anticonvulsant action of lamotrigine.","oneSentence":"Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:20.158Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Epilepsy (maintenance therapy)"},{"name":"Bipolar disorder (maintenance therapy for bipolar depression)"}]},"trialDetails":[{"nctId":"NCT00621842","phase":"PHASE3","title":"Lamotrigine for Symptoms of Geriatric Bipolar Depression","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2008-01","conditions":"Bipolar Disorder, Depression, Bipolar","enrollment":57}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lamictal"],"phase":"phase_3","status":"active","brandName":"Lamotrigine novel formulation","genericName":"Lamotrigine novel formulation","companyName":"University Hospitals Cleveland Medical Center","companyId":"university-hospitals-cleveland-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lamotrigine blocks voltage-gated sodium channels and inhibits glutamate release, reducing neuronal excitability. Used for Epilepsy (maintenance therapy), Bipolar disorder (maintenance therapy for bipolar depression).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}