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Opioid Analgesic

sufentanil sublingual tablet 30 mcg for Acute Pain

Phase 3
Waitlist Available
Research Sponsored by Talphera, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Eligible Conditions
  • Acute Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
Secondary study objectives
Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"
Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"
Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).

Side effects data

From 2016 Phase 3 trial • 140 Patients • NCT02662556
27%
Nausea
4%
Dizziness
3%
Pruritis
3%
Headache
2%
Oxygen saturation decreased
1%
Acute Stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sufentanil Sublingual Tablet (SST) 30 mcg

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: sufentanil sublingual tablet 30 mcgExperimental Treatment1 Intervention
sufentanil sublingual tablet 30 mcg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufentanil
FDA approved

Find a Location

Who is running the clinical trial?

Talphera, IncLead Sponsor
17 Previous Clinical Trials
2,182 Total Patients Enrolled
3 Trials studying Acute Pain
497 Patients Enrolled for Acute Pain
AcelRx Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
2,016 Total Patients Enrolled
3 Trials studying Acute Pain
497 Patients Enrolled for Acute Pain
Pamela P. Palmer, MD, PhDStudy DirectorTalphera, Inc
2 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Acute Pain
76 Patients Enrolled for Acute Pain
~14 spots leftby Nov 2025
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