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Also known as Oral sufentanil, sufentanil
Sufentanil/Triazolam NanoTab · 5 trials · 7 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 efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.
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 | ACTIVE_COMPARATOR | single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| 2 | PLACEBO_COMPARATOR | single dose of sublingual Placebo NanoTab™ |
| 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 | - |
| Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) | DRUG | Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| Placebo NanoTab™ | DRUG | Single dose of sublingual placebo NanoTab™ |
| 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/Triazolam NanoTab is an investigational sublingual small molecule therapy developed by Talphera, Inc. (TLPH) for acute moderate-to-severe pain, post-operative pain, and sedation. It combines sufentanil, an opioid analgesic, with triazolam and is delivered as a NanoTab formulation placed under the tongue.
Sufentanil/Triazolam NanoTab is being developed for acute moderate-to-severe pain, post-operative pain following major upper or lower abdominal surgery, and sedation. Talphera, Inc. (TLPH) is studying the sublingual formulation in adult patients, including those recovering from surgical procedures.
Sufentanil/Triazolam NanoTab targets OPRM1, the mu-opioid receptor, where sufentanil acts as an agonist. This receptor binding underlies the analgesic effect of the sufentanil component. The triazolam component is a benzodiazepine included in the combination NanoTab formulation.
Sufentanil/Triazolam NanoTab is developed by Talphera, Inc., which trades under the ticker TLPH. The company is advancing the sublingual sufentanil and triazolam combination as part of its pain and sedation pipeline.
Sufentanil/Triazolam NanoTab is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Talphera, Inc. (TLPH) has completed Phase 3 and Phase 2 trials evaluating the sublingual formulation in pain and sedation settings.
Completed trials include NCT02662556 and NCT02447848, both Phase 3 studies of the sufentanil sublingual 30 mcg tablet in acute pain, and NCT02356588, a Phase 3 trial in post-operative pain after abdominal surgery. NCT00894699 was a Phase 2 study of the ARX-F03 NanoTab in abdominal liposuction patients.