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Sufentanil/Triazolam NanoTab · 1 trial · 3 indications
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.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| 2 | PLACEBO_COMPARATOR | single dose of sublingual Placebo NanoTab™ |
| Name | Type | Description |
|---|---|---|
| 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™ |
Inclusion Criteria: 1. Patient must have provided written informed consent to participate in the study. 2. Male or female patient between 18 to 60 (inclusive) years of age. 3. Patient is planning to undergo an elective outpatient abdominal liposuction procedure. 4. Patient must be classified as Ame...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan, Astra-Zeneca |
| Cardinal Health, Inc. | CAH | 1 | - | Undisclosed |
| Medtronic Plc | MDT | 1 | N/A | Undisclosed |
Sufentanil is an investigational small molecule being developed for pain and sedation. Its studied indications include sedation, major upper or lower abdominal surgery, acute moderate-to-severe pain, moderate-to-severe acute pain, and post-operative pain. It is being evaluated in clinical trials for managing acute pain in various settings.
Sufentanil is being developed by Talphera, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TLPH. The company is conducting clinical trials to evaluate the drug's efficacy and safety for pain management indications.
Sufentanil is in Phase 3 clinical development. It has completed multiple Phase 3 trials, including studies for post-operative pain and acute pain. The drug is still investigational and has not been approved by regulatory authorities.
Sufentanil has completed several clinical trials, including NCT00718081, a Phase 2 study in major abdominal surgery; NCT02356588, a Phase 3 study in post-operative pain; NCT02447848, a Phase 3 study in moderate-to-severe acute pain; and NCT02662556, a Phase 3 study in acute moderate-to-severe pain. All trials were conducted in the United States.
Sufentanil is a small molecule that acts as an opioid analgesic. It works by binding to opioid receptors in the central nervous system to relieve pain. The drug is being developed as a sublingual tablet formulation for the management of acute pain.
Sufentanil is the active ingredient in the product formerly known as ARX-F01. In clinical trials, ARX-F01 referred to sublingual sufentanil tablets being evaluated for pain management. The drug is now referred to simply as sufentanil in later studies.