{"id":"placebo-sufentanil-nanotab-pca-system","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Sedation"},{"rate":null,"effect":"Respiratory depression"},{"rate":null,"effect":"Constipation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Sufentanil activates mu-opioid receptors throughout the brain and spinal cord, modulating pain perception and emotional response to pain. The NanoTab formulation delivers sufentanil through the oral mucosa for rapid absorption, while the PCA (patient-controlled analgesia) system allows patients to self-administer doses on demand within programmed safety limits.","oneSentence":"Sufentanil is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to provide rapid pain relief via patient-controlled analgesia.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:28:36.190Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute pain management in opioid-tolerant patients via patient-controlled analgesia"}]},"trialDetails":[{"nctId":"NCT01660763","phase":"PHASE3","title":"Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery","status":"COMPLETED","sponsor":"Talphera, Inc","startDate":"2012-08","conditions":"Post Operative Pain","enrollment":419},{"nctId":"NCT01539642","phase":"PHASE3","title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery","status":"COMPLETED","sponsor":"Talphera, Inc","startDate":"2012-02","conditions":"Post-Operative Pain","enrollment":172}],"_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":"phase_3","status":"active","brandName":"Placebo Sufentanil NanoTab PCA System","genericName":"Placebo Sufentanil NanoTab PCA System","companyName":"Talphera, Inc","companyId":"talphera-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sufentanil is a potent opioid agonist that binds to mu-opioid receptors in the central nervous system to provide rapid pain relief via patient-controlled analgesia. Used for Acute pain management in opioid-tolerant patients via patient-controlled analgesia.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}