{"id":"oros-mph-tablets","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Insomnia"},{"rate":"10-15","effect":"Decreased appetite"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Nervousness or anxiety"},{"rate":"5-10","effect":"Abdominal pain"},{"rate":"2-5","effect":"Tachycardia"},{"rate":"2-5","effect":"Elevated blood pressure"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Methylphenidate is a central nervous system stimulant that blocks the reuptake of dopamine and norepinephrine at the presynaptic neuron, increasing their availability in the synaptic cleft. The OROS (osmotic release oral system) delivery technology uses osmotic pressure to gradually release methylphenidate over 8-12 hours, providing consistent therapeutic levels and reducing the need for multiple daily doses. This mechanism enhances attention, focus, and impulse control in patients with attention deficit hyperactivity disorder.","oneSentence":"OROS MPH is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition throughout the day.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:59:08.113Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention deficit hyperactivity disorder (ADHD) in children and adults"}]},"trialDetails":[{"nctId":"NCT04507204","phase":"PHASE4","title":"Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD)","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2020-07-30","conditions":"Attention-Deficit/Hyperactivity Disorder","enrollment":267},{"nctId":"NCT00763971","phase":"PHASE3","title":"Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17","status":"COMPLETED","sponsor":"Shire","startDate":"2008-11-17","conditions":"ADHD","enrollment":336},{"nctId":"NCT00307684","phase":"PHASE3","title":"Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Janssen-Cilag International NV","startDate":"2006-01","conditions":"Attention Deficit Disorder With Hyperactivity","enrollment":155},{"nctId":"NCT01060150","phase":"PHASE4","title":"An Efficacy Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention-Deficit/Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2008-07","conditions":"Attention Deficit Disorder With Hyperactivity","enrollment":115},{"nctId":"NCT00937040","phase":"PHASE4","title":"Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Ortho-McNeil Janssen Scientific Affairs, LLC","startDate":"2009-07","conditions":"Attention Deficit Disorder With Hyperactivity","enrollment":357},{"nctId":"NCT00246207","phase":"PHASE3","title":"CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in Adults","status":"COMPLETED","sponsor":"Janssen-Ortho Inc., Canada","startDate":"2005-03","conditions":"Attention Deficit Disorder With Hyperactivity","enrollment":32},{"nctId":"NCT00269776","phase":"PHASE3","title":"An Effectiveness and Safety Study Evaluating OROS Methylphenidate Hydrochloride (HCl), Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder","status":"COMPLETED","sponsor":"Alza Corporation, DE, USA","startDate":"1998-11","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"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":"OROS MPH Tablets","genericName":"OROS MPH Tablets","companyName":"Ortho-McNeil Janssen Scientific Affairs, LLC","companyId":"ortho-mcneil-janssen-scientific-affairs-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OROS MPH is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition throughout the day. Used for Attention deficit hyperactivity disorder (ADHD) in children and adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}