{"id":"spd503-pm","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-10%","effect":"Dizziness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"It works by selectively binding to the serotonin receptor, which helps to reduce symptoms of certain conditions. This mechanism of action is thought to be beneficial for treating conditions such as obsessive-compulsive disorder and major depressive disorder.","oneSentence":"SPD503-PM is a small molecule drug that targets the serotonin receptor.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:35:47.851Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Obsessive-compulsive disorder"},{"name":"Major depressive disorder"}]},"trialDetails":[{"nctId":"NCT00734578","phase":"PHASE3","title":"Efficacy and Safety of SPD503 in Combination With Psychostimulants","status":"COMPLETED","sponsor":"Shire","startDate":"2008-09-02","conditions":"ADHD","enrollment":461},{"nctId":"NCT00997984","phase":"PHASE3","title":"Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)","status":"COMPLETED","sponsor":"Shire","startDate":"2009-11-17","conditions":"Attention-Deficit/Hyperactivity Disorder","enrollment":340}],"_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":["Intuniv"],"phase":"phase_3","status":"active","brandName":"SPD503-PM","genericName":"SPD503-PM","companyName":"Shire","companyId":"shire","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SPD503-PM is a small molecule drug that targets the serotonin receptor. Used for Obsessive-compulsive disorder, Major depressive disorder.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}