{"id":"prc-063","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Increased heart rate"},{"rate":null,"effect":"Anxiety"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PRC-063 is a once-daily extended-release methylphenidate product designed to maintain therapeutic levels throughout the day. Methylphenidate works by inhibiting the reuptake of dopamine and norepinephrine in the central nervous system, increasing their availability at synaptic sites. This mechanism helps improve attention, focus, and impulse control in patients with attention-deficit/hyperactivity disorder.","oneSentence":"PRC-063 is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition for ADHD symptom management.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:29:55.237Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention-deficit/hyperactivity disorder (ADHD) in children and adults"}]},"trialDetails":[{"nctId":"NCT03618030","phase":"PHASE3","title":"PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Purdue Pharma, Canada","startDate":"2018-08-21","conditions":"ADHD","enrollment":288},{"nctId":"NCT03172481","phase":"PHASE3","title":"PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD","status":"COMPLETED","sponsor":"Purdue Pharma, Canada","startDate":"2017-05-01","conditions":"ADHD","enrollment":156},{"nctId":"NCT02139124","phase":"PHASE3","title":"The Efficacy and Safety of PRC-063 in Adult ADHD Patients","status":"COMPLETED","sponsor":"Rhodes Pharmaceuticals, L.P.","startDate":"2014-04","conditions":"ADHD","enrollment":375},{"nctId":"NCT02555150","phase":"PHASE3","title":"A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD","status":"COMPLETED","sponsor":"Rhodes Pharmaceuticals, L.P.","startDate":"2015-09","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":40},{"nctId":"NCT02225639","phase":"PHASE3","title":"PRC-063 in an ADULT Workplace Environment","status":"COMPLETED","sponsor":"Rhodes Pharmaceuticals, L.P.","startDate":"2014-08","conditions":"Attention Deficit Hyperactivity Disorder (ADHD)","enrollment":60},{"nctId":"NCT02139111","phase":"PHASE3","title":"PRC-063 in Adolescent ADHD","status":"COMPLETED","sponsor":"Rhodes Pharmaceuticals, L.P.","startDate":"2014-04","conditions":"ADHD","enrollment":360},{"nctId":"NCT02168127","phase":"PHASE3","title":"Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD","status":"COMPLETED","sponsor":"Rhodes Pharmaceuticals, L.P.","startDate":"2014-05","conditions":"ADHD","enrollment":360}],"_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":["Methylphenidate"],"phase":"phase_3","status":"active","brandName":"PRC-063","genericName":"PRC-063","companyName":"Rhodes Pharmaceuticals, L.P.","companyId":"rhodes-pharmaceuticals-l-p","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PRC-063 is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition for ADHD symptom management. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adults.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}