Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ARX-F01
Sufentanil NanoTab · 2 trials · 2 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.
| 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 | - |
| 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 |
Inclusion Criteria: * patients scheduled for bunion surgery Exclusion Criteria: * daily opioid use * drug or alcohol abuse * pregnant or breastfeeding women
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
Sufentanil NanoTab is an investigational sublingual tablet formulation of sufentanil, a small molecule opioid analgesic. It is being developed by Talphera, Inc. (ticker TLPH) for the treatment of acute pain and post operative pain. It is in Phase 2 clinical development and is not FDA approved.
Sufentanil NanoTab is being studied for the management of acute pain and post operative pain. Completed Phase 2 trials have evaluated it in patients after bunionectomy and after elective unilateral total knee replacement. It remains an investigational product and has not been approved for any indication.
Sufentanil NanoTab targets OPRM1, the mu opioid receptor, and acts as an agonist at that receptor. This is the same receptor class engaged by other opioid analgesics used for acute and post operative pain. The NanoTab formulation is designed for sublingual administration.
Sufentanil NanoTab is being developed by Talphera, Inc., which trades under the ticker TLPH. Talphera is the sponsor of the clinical program evaluating the sublingual sufentanil tablet in acute pain and post operative pain settings.
Sufentanil NanoTab is in Phase 2 clinical development. It is an investigational drug and is not FDA approved. The completed Phase 2 studies were randomized, double blind, and placebo controlled, and no active trials of Sufentanil NanoTab are currently listed.
Two completed Phase 2 trials are registered for Sufentanil NanoTab. NCT01710345 evaluated safety and efficacy for acute pain following bunionectomy in 101 patients. NCT00612534 evaluated sublingual sufentanil, listed as ARX-F01, in 94 patients undergoing elective unilateral total knee replacement for post operative pain. Both were conducted in the United States.