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Placebo Sufentanil NanoTab PCA System
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.
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.
At a glance
| Generic name | Placebo Sufentanil NanoTab PCA System |
|---|---|
| Sponsor | Talphera, Inc |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor (μ-OR) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Acute pain management in opioid-tolerant patients via patient-controlled analgesia
Common side effects
- Nausea
- Dizziness
- Sedation
- Respiratory depression
- Constipation
Key clinical trials
- 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 (PHASE3)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo Sufentanil NanoTab PCA System CI brief — competitive landscape report
- Placebo Sufentanil NanoTab PCA System updates RSS · CI watch RSS
- Talphera, Inc portfolio CI