Trial Outcomes & Findings for Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy (NCT NCT05553366)
NCT ID: NCT05553366
Last Updated: 2025-08-01
Results Overview
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).
COMPLETED
PHASE3
1075 participants
0 to 48 hours After First Dose of Study Drug
2025-08-01
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 2 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
216
|
431
|
428
|
|
Overall Study
Safety Set
|
216
|
431
|
426
|
|
Overall Study
COMPLETED
|
208
|
419
|
418
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to suzetrigine (SUZ) and hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg every 12 hours (q12h)\] for 2 days.
|
|---|---|---|---|
|
Overall Study
Withdrawal of Consent (not due to AE
|
4
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
3
|
|
Overall Study
Other non-compliance
|
1
|
1
|
0
|
|
Overall Study
Randomized but not dosed
|
0
|
0
|
2
|
Baseline Characteristics
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Baseline characteristics by cohort
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
n=431 Participants
Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Total
n=1073 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=5 Participants
|
359 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
912 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
84 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
364 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
132 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
709 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
160 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
759 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
48 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 to 48 hours After First Dose of Study DrugPopulation: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
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).
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to Placebo
|
70.6 units on a scale
Standard Error 6.3
|
99.9 units on a scale
Standard Error 4.5
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure.
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 post dose 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).
Outcome measures
| Measure |
Placebo
n=431 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48), SUZ Compared to HB/APAP
|
120.1 units on a scale
Standard Error 4.5
|
99.9 units on a scale
Standard Error 4.5
|
—
|
SECONDARY outcome
Timeframe: From Baseline Up to 48 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥ 2-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 2-point reduction in NPRS scores from baseline.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo
|
480 minutes
Interval 476.0 to 716.0
|
240 minutes
Interval 117.0 to 477.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline Up to 48 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The time to ≥1-point reduction in NPRS from baseline was the time elapsed from the first dose of study drug until the first time the participant had at least a 1-point reduction in NPRS from baseline.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo
|
61 minutes
Interval 34.0 to 121.0
|
60 minutes
Interval 58.0 to 65.0
|
—
|
SECONDARY outcome
Timeframe: At 48 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
The PGA is a single-item assessment of patient perceptions of the method of pain control with the study drug and is evaluated on a 4-point Likert scale as: (poor, fair, good, or excellent). Percentage of participants who reported good or excellent on the PGA scale were reported.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo
|
53.2 percentage of participants
|
61.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to Day 19Population: Safety Set included all participants who received at least 1 dose of study drug. Data for this outcome measure was planned to be collected and analyzed only for the HB/APAP and SUZ group.
The percentage of participants with the events of vomiting or nausea during the specified time frame was reported.
Outcome measures
| Measure |
Placebo
n=431 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP
|
16.5 percentage of participants
|
9.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
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 post dose time point (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo
|
19.8 units on a scale
Standard Error 3.0
|
30.6 units on a scale
Standard Error 2.1
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Time to First Use of Rescue Medication, SUZ Compared to Placebo
|
185 minutes
Interval 143.0 to 210.0
|
157 minutes
Interval 145.0 to 192.0
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo
|
85.6 percentage of participants
|
85.4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First Dose of Study DrugPopulation: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. Data for this outcome measure was planned to be collected and analyzed only for the Placebo and SUZ group.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Total Rescue Medication Usage, SUZ Compared to Placebo
|
800 milligram
Interval 0.0 to 3200.0
|
800 milligram
Interval 0.0 to 3200.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 19Population: Safety Set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=216 Participants
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Suzetrigine (SUZ)
n=431 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
Suzetrigine (SUZ)
n=426 Participants
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days
|
|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
76 Participants
|
180 Participants
|
132 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
Suzetrigine (SUZ)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=216 participants at risk
Participants received placebo matched to SUZ and HB/APAP for 2 days.
|
Hydrocodone Bitartrate/Acetaminophen (HB/APAP)
n=431 participants at risk
Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.
|
Suzetrigine (SUZ)
n=426 participants at risk
Participants received SUZ \[100 mg as first dose, followed by 50 mg q12h\] for 2 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.2%
9/216 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
5.1%
22/431 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
3.5%
15/426 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.6%
23/216 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
14.4%
62/431 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
8.2%
35/426 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
5.1%
11/216 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
5.3%
23/431 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
3.5%
15/426 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Headache
|
9.3%
20/216 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
10.4%
45/431 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
4.9%
21/426 • Day 1 up to Day 19
Safety Set included all participants who received at least 1 dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place