Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Suzetrigine · 10 trials · 4 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 by 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).
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
| Arm | Type | Description |
|---|---|---|
| Suzetrigine (SUZ) | EXPERIMENTAL | Participants will be randomized to receive SUZ. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to SUZ. |
| Pregabalin | ACTIVE_COMPARATOR | Participants will be randomized to receive Pregabalin. |
| Hydrocodone bitartrate/acetaminophen (HB/APAP) | ACTIVE_COMPARATOR | Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 48 hours. |
| Suzetrigine (SUZ): Low Dose | EXPERIMENTAL | Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks. |
| Suzetrigine (SUZ): Mid Dose | EXPERIMENTAL | Participants received SUZ 46 mg tablet qd for 12 weeks. |
| Suzetrigine (SUZ): High Dose | EXPERIMENTAL | Participants received SUZ 69 mg tablet qd for 12 weeks. |
| SUZ and Efavirenz | EXPERIMENTAL | Participants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30. |
| SUZ | EXPERIMENTAL | Participants will receive a single dose of SUZ on Day 1. |
| Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) | EXPERIMENTAL | Participants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25. |
| Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) | EXPERIMENTAL | Participants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29. |
| Part A | EXPERIMENTAL | Participants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period. |
| Part B | EXPERIMENTAL | Participants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period. |
| Name | Type | Description |
|---|---|---|
| Suzetrigine | DRUG | Tablets for oral administration |
| Placebo (matched to SUZ) | DRUG | Placebo matched to SUZ for oral administration. |
| Pregabalin | DRUG | Capsules for oral administration. |
| Placebo (matched to Pregabalin) | DRUG | Placebo matched to Pregabalin for oral administration. |
| Suzetrigine (SUZ) | DRUG | Tablets for oral administration. |
| HB/APAP | DRUG | Capsules for oral administration. |
| Placebo (matched to HB/APAP) | DRUG | Placebo matched to HB/APAP for oral administration. |
| Efavirenz | DRUG | Tablet for oral administration. |
| DRSP/EE | DRUG | Combination Tablets for Oral Administration. |
| NGM/EE | DRUG | Combination Tablets for Oral Administration. |
Key Inclusion Criteria: * Body weight greater than or equal to (≥)45 kilogram (kg) * Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pa...
| 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 |
Suzetrigine is an investigational small molecule being developed for pain, including acute pain, diabetic peripheral neuropathic pain, and diabetic peripheral neuropathy. It is currently in Phase 3 clinical development and is not yet approved by the FDA.
Suzetrigine is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the drug's efficacy and safety for pain indications.
Suzetrigine is in Phase 3 clinical development for pain indications. It has completed Phase 3, Phase 2, and Phase 1 trials, and remains investigational. The drug is not yet approved by the FDA and is still undergoing clinical evaluation.
Suzetrigine has been studied in several clinical trials, including NCT05558410 for acute pain after abdominoplasty, NCT05660538 for painful diabetic peripheral neuropathy, NCT06336096 for bioavailability and food effect, and NCT06820307 for effects on oral contraceptives. These trials are completed.
Yes, Suzetrigine is also known as VX-548. In clinical trials, it has been referred to by both names, such as in the study NCT05660538, which evaluates VX-548 for painful diabetic peripheral neuropathy.