Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sufentanil NanoTab · 3 trials · 3 indications
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 SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.
| Arm | Type | Description |
|---|---|---|
| Sufentanil NanoTab 20 mcg | EXPERIMENTAL | Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours |
| Sufentanil NanoTab 30 mcg | EXPERIMENTAL | Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours |
| Placebo NanoTab | PLACEBO_COMPARATOR | Placebo NanoTab as needed every 60 minutes for 12 hours |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | PLACEBO_COMPARATOR | - |
| SUF NT 15 mcg | EXPERIMENTAL | Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
| Ketoconazole 400 mg, SUF NT 15 mcg | EXPERIMENTAL | Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. |
| Name | Type | Description |
|---|---|---|
| Sufentanil NanoTab 20 mcg | DRUG | - |
| Sufentanil NanoTab 30 mcg | DRUG | - |
| Placebo NanoTab | DRUG | - |
| Sufentanil NanoTab | DRUG | 5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours |
| Sufentanil NanoTab (SUF NT) 15 mcg | DRUG | Period 1: One dose of SUF NT 15 mcg administered sublingually |
| Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg | DRUG | Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day |
Inclusion Criteria: * patients scheduled for bunion surgery Exclusion Criteria: * daily opioid use * drug or alcohol abuse * pregnant or breastfeeding women
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
Sufentanil NanoTab is an investigational small molecule being developed for the management of acute pain and post-operative pain. It has been studied in clinical trials for pain following procedures such as total knee replacement and bunionectomy. The drug is administered sublingually and is currently in Phase 2 clinical development.
Sufentanil NanoTab targets opioid receptors in the body. As a sufentanil formulation, it acts as an opioid analgesic, binding to mu-opioid receptors to produce pain relief. This mechanism is typical of potent opioid medications used for managing acute and post-operative pain.
Sufentanil NanoTab is being developed by Talphera, Inc., a biopharmaceutical company. Talphera is publicly traded on the NASDAQ under the ticker symbol TLPH. The company is conducting clinical trials to evaluate the safety and efficacy of this sublingual sufentanil formulation for pain management.
Sufentanil NanoTab is currently in Phase 2 clinical development. It has completed Phase 2 trials for post-operative pain and acute pain following bunionectomy. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development to assess its safety and efficacy.
Sufentanil NanoTab has been studied in several clinical trials. NCT00612534 was a Phase 2 study in patients undergoing total knee replacement. NCT01710345 was a Phase 2 study for acute pain following bunionectomy. NCT01721070 was a Phase 1 pharmacokinetic study. All three trials have been completed.
Sufentanil NanoTab is also known as ARX-F01. In clinical trials, it has been referred to by this alternative name. For example, NCT00612534 evaluated the efficacy and safety of ARX-F01 sublingual sufentanil in patients undergoing total knee replacement. Both names refer to the same investigational drug.