| Primary | 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 | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 0 to 48 hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00070.6± 6.3
- OG00199.9± 4.5
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.0002 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | 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 | 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). | FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this specific outcome measure. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 0 to 48 hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Participants received HB 5 mg/ APAP 325 mg q6h for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Time to Greater Than or Equal to (≥)2-Point Reduction in NPRS,SUZ Compared to Placebo | 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. | 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. | Posted | | Median | 95% Confidence Interval | minutes | | From Baseline Up to 48 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Time to ≥1-Point Reduction in NPRS, SUZ Compared to Placebo | 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. | 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. | Posted | | Median | 95% Confidence Interval | minutes | | From Baseline Up to 48 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Percentage of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Scale, SUZ Compared to Placebo | 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. | 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. | Posted | | Number | | percentage of participants | | At 48 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Incidence of Vomiting or Nausea, SUZ Compared to HB/APAP | The percentage of participants with the events of vomiting or nausea during the specified time frame was reported. | 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. | Posted | | Number | | percentage of participants | | From Baseline up to Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Participants received HB 5 mg/ APAP 325 mg q6h for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Time-weighted SPID as Recorded on the NPRS From 0 to 24 Hours (SPID24), SUZ Compared to Placebo | 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). | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | 0 to 24 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days |
| |
| Secondary | Time to First Use of Rescue Medication, SUZ Compared to Placebo | Time to first use of rescue medication is the time from the first dose of study drug until the first use of rescue medication. | 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. | Posted | | Median | 95% Confidence Interval | minutes | | 0 to 48 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days |
| |
| Secondary | Percentage of Participants Using Rescue Medication From 0 to 48 Hours, SUZ Compared to Placebo | | 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. | Posted | | Number | | percentage of participants | | 0 to 48 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Total Rescue Medication Usage, SUZ Compared to Placebo | | 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. | Posted | | Median | Full Range | milligram | | 0 to 48 Hours After First Dose of Study Drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days. |
| |
| Secondary | Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | | Safety Set included all participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | No | Day 1 up to Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to SUZ and HB/APAP for 2 days. | | OG001 | Hydrocodone Bitartrate/Acetaminophen (HB/APAP) | Participants received HB 5 mg/ APAP 325 mg q6h for 2 days | | OG002 | Suzetrigine (SUZ) | Participants received SUZ [100 mg as first dose, followed by 50 mg q12h] for 2 days |
| |