Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SUZ · 2 trials · 2 indications
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated subtracting the baseline pain intensity score from the pain intensity score at each postdose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days. |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days. |
| Suzetrigine (SUZ) | EXPERIMENTAL | Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 2 days. |
| SUZ | EXPERIMENTAL | Participants will be given SUZ SDD to retain in their mouths for approximately 10 seconds and then expectorate. |
| Name | Type | Description |
|---|---|---|
| SUZ | DRUG | Tablets for oral administration. |
| HB/APAP | DRUG | Capsules for oral administration. |
| Placebo (matched to SUZ) | DRUG | Placebo matched to SUZ for oral administration. |
| Placebo (matched to HB/APAP) | DRUG | Placebo matched to HB/APAP for oral administration. |
Key Inclusion Criteria: * Before Surgery * Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block) * After Surgery * Participant is lu...
| 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 |
SUZ, also known as suzetrigine, is an investigational small molecule being developed for the treatment of acute pain and pain. It is currently in Phase 3 clinical development for acute pain, with a completed Phase 3 trial evaluating its efficacy and safety after a bunionectomy.
SUZ is a small molecule that targets pain pathways. As a selective NaV1.8 inhibitor, it works by blocking the NaV1.8 sodium channel, which plays a key role in pain signaling. This mechanism is being studied for its potential to provide pain relief without the risks associated with opioids.
SUZ is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. Vertex is conducting clinical trials to evaluate the safety and efficacy of SUZ for pain indications.
SUZ is in Phase 3 clinical development for acute pain. A Phase 3 trial (NCT05553366) has been completed, and a Phase 1 study (NCT06834009) has also been completed. SUZ is investigational and not yet approved by regulatory authorities.
SUZ has been studied in two completed clinical trials. The Phase 3 trial NCT05553366 evaluated the efficacy and safety of VX-548 for acute pain after a bunionectomy in 1075 participants. The Phase 1 trial NCT06834009 studied suzetrigine spray-dried dispersion in healthy adult panelists.
Yes, SUZ is also known as suzetrigine and was previously referred to as VX-548 in clinical trials. The Phase 3 trial NCT05553366 used the name VX-548, while the Phase 1 trial used the name suzetrigine (SUZ). Both names refer to the same investigational drug.