Approval Probability
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Adjusted LOA
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sufentanil · 4 trials · 4 indications
The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity \[PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.
| Arm | Type | Description |
|---|---|---|
| sufentanil sublingual tablet 30 mcg | EXPERIMENTAL | sufentanil sublingual tablet 30 mcg |
| Sufentanil Tablet 30 mcg | EXPERIMENTAL | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. |
| Placebo Tablet | PLACEBO_COMPARATOR | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. |
| 1 | EXPERIMENTAL | Oral Sufentanil |
| 2 | EXPERIMENTAL | Oral sufentanil |
| 3 | PLACEBO_COMPARATOR | Oral dosage of placebo |
| Name | Type | Description |
|---|---|---|
| sufentanil sublingual tablet 30 mcg | DRUG | sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours. |
| sufentanil sublingual 30 mcg tablet | DRUG | - |
| Sufentanil Tablet 30 mcg | DRUG | - |
| Placebo Tablet | DRUG | - |
| Oral sufentanil | DRUG | Oral dosage of sufentanil |
| Placebo | DRUG | Oral dosage of placebo |
Inclusion Criteria: 1. Male or female patients who are 40 years of age or older. 2. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. 3. Patients classified as American Society of Anesthesiol...
Sufentanil is an opioid analgesic being developed for acute moderate-to-severe pain, sedation, moderate-to-severe acute pain, and post-operative pain, including pain following major upper or lower abdominal surgery. It is administered as a sublingual tablet and is currently in Phase 3 clinical development.
Sufentanil is an opioid analgesic that works by binding to opioid receptors in the central nervous system to relieve pain. It is being studied for the management of acute moderate-to-severe pain, including post-operative pain.
Sufentanil is being developed by Talphera, Inc., a biopharmaceutical company. Talphera is publicly traded on the Nasdaq under the ticker symbol TLPH.
Sufentanil is in Phase 3 clinical development for acute pain indications. It has completed multiple clinical trials, including Phase 2 and Phase 3 studies, but is not yet approved by the FDA and remains investigational.
Sufentanil has been studied in several completed clinical trials, including NCT00718081, a Phase 2 study in patients undergoing major abdominal surgery; NCT00894699, a Phase 2 study for sedation and pain; NCT02447848, a Phase 3 study for acute pain; and NCT02662556, a Phase 3 study for post-operative pain.
Sufentanil has been studied under the names ARX-F01 and ARX-F03 in clinical trials. ARX-F01 is a sublingual sufentanil formulation evaluated for post-operative pain, while ARX-F03 is a sublingual sufentanil/triazolam combination studied for sedation and pain.