{"id":"spn-812-600mg-qd","safety":{"commonSideEffects":[{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Increased blood pressure"},{"rate":null,"effect":"Increased heart rate"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SPN-812 selectively inhibits the norepinephrine transporter, preventing reuptake of norepinephrine at the synaptic cleft. This increases norepinephrine concentration in brain regions associated with attention, impulse control, and executive function. The drug is designed to treat attention-deficit/hyperactivity disorder (ADHD) with a mechanism distinct from traditional stimulants.","oneSentence":"SPN-812 is a selective norepinephrine reuptake inhibitor that increases norepinephrine availability in the central nervous system to improve attention and executive function.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:08:58.832Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents"}]},"trialDetails":[{"nctId":"NCT06259331","phase":"PHASE4","title":"Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2023-05-23","conditions":"Healthy Lactating Women","enrollment":15},{"nctId":"NCT03247556","phase":"PHASE3","title":"Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD","status":"COMPLETED","sponsor":"Supernus Pharmaceuticals, Inc.","startDate":"2017-11-20","conditions":"ADHD","enrollment":297}],"_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":[],"phase":"marketed","status":"active","brandName":"SPN-812 (600mg, QD)","genericName":"SPN-812 (600mg, QD)","companyName":"Supernus Pharmaceuticals, Inc.","companyId":"supernus-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SPN-812 is a selective norepinephrine reuptake inhibitor that increases norepinephrine availability in the central nervous system to improve attention and executive function. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}