Drug Trials Snapshots: JOURNAVX
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the JOURNAVX Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
JOURNAVX (suzetrigine)
jore na' vix
Vertex Pharmaceuticals Inc.
Approval date: January 30, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
JOURNAVX is a sodium channel blocker that is indicated for the treatment of moderate to severe acute pain in adults.
How is this drug used?
JOURNAVX is a tablet. The recommended starting dose of JOURNAVX is 100 mg orally. Starting 12 hours after the initial dose, 50 mg of JOURNAVX is taken orally every 12 hours.
Who participated in the clinical trials?
JThe FDA approved JOURNAVX based on evidence from three clinical trials (Trial 1/NCT05558410, Trial 2/NCT05553366, and Trial 3/NCT05661734) of 2,447 patients with moderate to severe acute pain after a surgical procedure or due to a nonsurgical condition. The trials were conducted at 46 sites in the United States.
How were the trials designed?
Trial 1 enrolled patients who underwent surgical removal of abdominal wall fat and skin (abdominoplasty). Trial 2 enrolled patients who underwent bunion surgery. In both trials, patients with moderate to severe post-surgical pain were randomly assigned to receive oral JOURNAVX, placebo, or an approved drug to treat pain (hydrocodone bitartrate/acetaminophen [HB/APAP]) for a duration of 48 hours. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. All patients were allowed to use a rescue pain medication if the pain was not well controlled using the trial medications.
To assess the benefits of JOURNAVX in Trials 1 and 2, patients used a numerical scale to score how severe the pain was after the surgery. The scores for the patients who received JOURNAVX were compared to the scores for the patients who received placebo and those who received HB/APAP.
In Trial 3, patients who had moderate to severe acute pain after various types of surgical procedures or due to a nonsurgical condition received at least one dose of JOURNAVX. Data from this trial were used to assess the safety of JOURNAVX.
How were the trials designed?
The efficacy and safety of JOURNAVX in the treatment of moderate to severe acute pain in adults was established in two randomized, double-blind, placebo- and active-controlled trials of acute pain, one following full abdominoplasty (Trial 1) and the other following bunionectomy (Trial 2). In each trial, pain intensity was measured using a patient-reported 11-point numeric pain rating scale (NPRS), ranging from 0 to 10, where zero corresponds to no pain and 10 corresponds to the worst pain imaginable.
Patients were eligible for study participation if they had moderate to severe pain on the verbal categorical rating system and a pain score of ≥4 on the NPRS, within four hours of the abdominoplasty completion (Trial 1) or during the nine hour period after discontinuation of regional anesthesia following bunionectomy (Trial 2). Once eligible, patients were randomized to receive oral JOURNAVX, placebo, or HB/APAP for a duration of 48 hours. For the JOURNAVX treatment regimen, patients received an initial loading dose of 100 mg JOURNAVX, followed by 50 mg every 12 hours. For the HB/APAP-control regimen, patients received 5 mg/325 mg every six hours. For both studies, 400 mg of ibuprofen every six hours, as needed for pain relief, was permitted as a rescue medication.
The analgesic effect was measured using the time-weighted sum of the pain intensity difference (SPID) as recorded on the NPRS from 0 to 48 hours (SPID48). The SPID is calculated by multiplying the Pain Intensity Difference scores (calculated by subtracting the pain intensity at baseline from the pain intensity at a particular timepoint) at each post-baseline timepoint by the duration (in hours) since the preceding timepoint and then summing the values over 48 hours.
Trial 3 was an open-label evaluation of patients with moderate to severe acute pain following a surgical procedure or due to a nonsurgical condition who received at least one dose of JOURNAVX. Patients received 100 mg as a first dose, then 50 mg every 12 hours and continued to receive JOURNAVX for up to 14 days or until their pain resolved. Rescue medication of 650 mg of acetaminophen and 400 mg of ibuprofen together every six hours was permitted as needed for pain relief.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of JOURNAVX.
Figure 1. Demographics by Sex, Safety Population
Source: Adapted from FDA Review
Figure 2 summarizes how many patients by race were enrolled in the combined clinical trials used to evaluate the efficacy of JOURNAVX.
Figure 2. Demographics by Race, Safety Population
Source: Clinical Trial Data
Figure 3 summarizes how many patients by age were enrolled in the combined clinical trials used to evaluate the efficacy of JOURNAVX.
Figure 3. Demographics by Age, Safety Population
Source: Clinical Trial Data
Figure 4 summarizes how many patients by ethnicity were enrolled in the combined clinical trials used to evaluate the efficacy of JOURNAVX.
Figure 4. Demographics by Ethnicity, Safety Population
Source: Clinical Trial Data
Who participated in the trials?
Table 1 summarizes the demographics of all patients from Trials 1, 2, and 3.
Table 1. Demographic Characteristics for Trials 1, 2, and 3
| Characteristic | Trial 1 N=1118 | Trial 2 N=1073 | Trial 3 N=256 | Total N=2447 |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Female | 1098 (98.2) | 912 (85.0) | 173 (67.6) | 2183 (89.2) |
| Male | 20 (1.8) | 161 (15.0) | 83 (32.4) | 264 (10.8) |
| Age, years | ||||
| Mean (SD) | 41.8 (8.8) | 48 (13.1) | 43.9 (14.1) | 44.7 (11.8) |
| Median (min, max) | 41 (18, 69) | 49 (18, 75) | 43 (18, 78) | 44 (18, 78) |
| Age group, years, n (%) | ||||
| ≥18 to <65 | 1113 (99.6) | 973 (90.7) | 232 (90.6) | 2318 (94.7) |
| ≥65 | 5 (0.4) | 100 (9.3) | 24 (9.4) | 129 (5.3) |
| Race, n (%) | ||||
| White | 778 (69.6) | 759 (70.7) | 214 (83.6) | 1751 (71.6) |
| Black or African American | 299 (26.7) | 260 (24.2) | 34 (13.3) | 593 (24.2) |
| Asian | 16 (1.4) | 24 (2.2) | 3 (1.2) | 43 (1.8) |
| American Indian or Alaska Native | 6 (0.5) | 11 (1.0) | 3 (1.2) | 20 (0.8) |
| Native Hawaiian or other Pacific Islander | 9 (0.8) | 2 (0.2) | 1 (0.4) | 12 (0.5) |
| Multiple | 8 (0.7) | 9 (0.8) | 1 (0.4) | 18 (0.7) |
| Other | 2 (0.2) | 5 (0.5) | 0 (0) | 7 (0.3) |
| Missing | 0 (0) | 3 (0.3) | 0 (0) | 3 (0.1) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 380 (34.0) | 364 (33.9) | 108 (42.2) | 852 (34.8) |
| Not Hispanic or Latino | 735 (65.7) | 709 (66.1) | 148 (57.8) | 1592 (65.1) |
| Missing | 3 (0.3) | 0 (0) | 0 (0) | 3 (0.1) |
| Country of participation, n (%) | ||||
| United States | 1118 (100) | 1073 (100) | 256 (100) | 2447 (100) |
Source: Clinical Trial Data
Abbreviations: SD, standard deviation
What are the benefits of this drug?
JOURNAVX reduces post-surgical pain.
What are the benefits of this drug (results of trials used to assess efficacy)?
In Trial 1, a total of 1,118 patients were randomized 2:2:1 to receive JOURNAVX (N=447), HB/APAP (N=448), or placebo (N=223). In Trial 2, a total of 1,073 patients were randomized 2:2:1 to receive JOURNAVX (N=426), HB/APAP (N=431), or placebo (N=216). The primary efficacy endpoint was a comparison of the time-weighted SPID as recorded on the NPRS from 0 to 48 hours (SPID48) between the JOURNAVX and placebo. In both trials, there was a statistically significant difference in the SPID48 in the JOURNAVX group compared to the placebo group. Table 2 summarizes the primary efficacy results for Trials 1 and 2.
The first key secondary efficacy endpoint was a comparison of the SPID48 between the JOURNAVX and HB/APAP. In Trial 1, the least squares (LS) mean for HB/APAP was 111.8, which was 6.6 lower than JOURNAVX in SPID48. In Trail 2, the LS mean for HB/APAP was 120.1, which was 20.2 higher than JOURNAVX in SPID48.
In an exploratory analysis, the time-weighted SPID from 0 to 24 hours (SPID24) was reported. The LS mean was 48.0 in the JOURNAVX group and 24.2 in the placebo group in Trial 1. The LS mean was 30.6 in the JOURNAVX group and 19.8 in the placebo group in Trial 2.
Table 2. SPID48 Results in Adults With Moderate to Severe Acute Pain
| Efficacy Measure | Trial 1: Full Abdominoplasty | Trial 2: Bunionectomy | ||
|---|---|---|---|---|
JOURNAVX N=447 | Placebo N=223 | JOURNAVX N=426 | Placebo N=216 | |
| LS meana | 118.4 | 70.1 | 99.9 | 70.6 |
| LS mean difference (95% CI) | 48.4 (33.6, 63.1) | 29.3 (14.0, 44.6) | ||
| P-value | <0.0001 | 0.0002 | ||
Source: JOURNAVX Prescribing Information
a A larger value of LS mean indicates better efficacy measured by SPID48.
Abbreviations: CI, confidence interval; LS, least squares; SPID48, sum of the pain intensity difference from 0 to 48 hours
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: The number of male patients was small; therefore, differences in how JOURNVAX worked among sex groups could not be determined.
- Race: In Trial 1, JOURNVAX worked similarly in White and Black or African American patients. The number of patients of other races was limited; therefore, differences in response for other races could not be determined. In Trial 2, the observed effect of JOURNVAX was similar in White and Black or African American patients. The number of patients of other races was small; therefore, differences in how the drug worked in other races could not be determined.
- Age: The number of patients 65 years of age or older was small; therefore, differences in how JOURNVAX worked among age groups could not be determined.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 3 summarizes efficacy results by subgroup for Trials 1 and 2.
Table 3. Subgroup Analysis for SPID48 Efficacy Results
| Group | Subgroup | JOURNAVX Difference From Placebo (95% CI) | |
|---|---|---|---|
| Trial 1 | Trial 2 | ||
| Sex | Female | 49.2 (34.3, 64.1) | 27.0 (10.3, 43.7) |
| Male | NA* | 40.3 (2.1, 78.6) | |
| Race | White | 43.9 (26.6, 61.2) | 32.7 (14.7, 50.7) |
| Black or African American | 58.5 (27.9, 89.0) | 17.8 (-15.1, 50.7) | |
| Age, years | ≥18 to <65 | 48.4 (33.6, 63.2) | 30.3 (14.1, 46.5) |
| ≥65 | NA* | 16.5 (-30.2, 63.1) | |
Source: Adapted from the FDA Review
* Too few subjects (<10) in either study arm for evaluation
Abbreviations: CI, confidence interval; NA, not applicable; SPID48, sum of the pain intensity difference from 0 to 48 hours
What are the possible side effects?
The most common side effects of JOURNAVX in clinical trials were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
What are the possible side effects (results of trials used to assess safety)?
Table 4 summarizes adverse reactions in patients with moderate to severe pain in the pooled controlled Phase 3 trials (Trials 1 and 2).
Table 4. Adverse Reactions Reported in ≥1% of JOURNAVX-Treated Patients and Greater Than Rate of Placebo in Trials 1 and 2
| Adverse Reactions | JOURNAVX N=874 n (%) | HB/APAP N=879 n (%) | Placebo N=438 n (%) |
|---|---|---|---|
| Pruritus | 18 (2.1) | 30 (3.4) | 7 (1.6) |
| Muscle spasms | 11 (1.3) | 6 (0.7) | 2 (0.5) |
| Increased blood creatine phosphokinase | 10 (1.1) | 7 (0.8) | 2 (0.5) |
| Rash | 10 (1.1) | 6 (0.7) | 2 (0.5) |
Source: JOURNAVX Prescribing Information
Abbreviations: HB/APAP, hydrocodone bitartrate/acetaminophen
Were there any differences in side effects among sex, race, and age?
- Sex: The number of male patients was small; therefore, differences between male and female patients in side effects from JOURNAVX could not be determined.
- Race: The number of patients of races other than White was relatively small; therefore, differences among races in side effects from JOURNAVX could not be determined.
- Age: The number of patients 65 years of age and older was small; therefore, differences between patients 18 to less than 65 years of age and patients 65 years of age and older from JOURNAVX could not be determined.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 5, Table 6, and Table 7 summarize the occurrence of adverse reactions reported in ≥1% of JOURNAVX-treated patients and greater than rate of placebo in the pooled controlled Phase 3 trials (Trials 1 and 2) by subgroup.
Table 5. Adverse Reactions by Sex
| Characteristic | JOURNAVX N=874 n/Ns (%) | HB/APAP N=879 n/Ns (%) | Placebo N=438 n/Ns (%) | |||
|---|---|---|---|---|---|---|
| Female | Male | Female | Male | Female | Male | |
| Number of subjects with at least one AE | 334/804 (41.5) | 22/70 (31.4) | 432/800 (54.0) | 20/79 (25.3) | 189/406 (46.6) | 12/32 (37.5) |
| Selected adverse reactions | ||||||
| Pruritus | 16/804 (2.0) | 2/70 (2.9) | 27/800 (3.4) | 3/79 (3.8) | 7/406 (1.7) | 0/32 (0) |
| Muscle spasms | 9/804 (1.1) | 2/70 (2.9) | 6/800 (0.8) | 0/79 (0) | 2/406 (0.5) | 0/32 (0) |
| Blood creatine phosphokinase increased | 9/804 (1.1) | 1/70 (1.4) | 6/800 (0.8) | 1/79 (1.3) | 2/406 (0.5) | 0/32 (0) |
| Rash | 9/804 (1.1) | 1/70 (1.4) | 6/800 (0.8) | 0/79 (0) | 2/406 (0.5) | 0/32 (0) |
Source: Clinical Trial Data
Abbreviations: AE, adverse event; HB/APAP, hydrocodone bitartrate/acetaminophen; N, number of patients in treatment arm; n, number of patients with adverse event; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
Table 6. Adverse Reactions by Race
| Characteristic | Race | JOURNAVX N=874 n/Ns (%) | HB/APAP N=879 n/Ns (%) | Placebo N=438 n/Ns (%) |
|---|---|---|---|---|
| Number of subjects with at least one AE | American Indian or Alaska Native | 2/9 (22.2) | 6/7 (85.7) | 0/1 (0) |
| Asian | 9/16 (56.2) | 11/16 (68.8) | 5/8 (62.5) | |
| Black or African American | 87/239 (36.4) | 90/210 (42.9) | 46/110 (41.8) | |
| Multiple | 6/8 (75.0) | 4/7 (57.1) | 1/2 (50.0) | |
| Native Hawaiian or other Pacific Islander | 1/4 (25.0) | 3/6 (50.0) | 1/1 (100) | |
| Other | 1/3 (33.3) | 0/2 (0) | 2/2 (100) | |
| White | 249/593 (42.0) | 337/630 (53.5) | 146/314 (46.5) | |
| Missing | 1/2 (50.0) | 1/1 (100) | 0/0 (NA) | |
| Selected adverse reactions | ||||
| Pruritus | American Indian or Alaska Native | 1/9 (11.1) | 0/7 (0) | 0/1 (0) |
| Asian | 1/16 (6.2) | 1/16 (6.2) | 0/8 (0) | |
| Black or African American | 7/239 (2.9) | 11/210 (5.2) | 1/110 (0.9) | |
| Multiple | 1/8 (12.5) | 0/7 (0) | 0/2 (0) | |
| Native Hawaiian or other Pacific Islander | 0/4 (0) | 0/6 (0) | 0/1 (0) | |
| Other | 0/3 (0) | 0/2 (0) | 0/2 (0) | |
| White | 8/593 (1.3) | 18/630 (2.9) | 6/314 (1.9) | |
| Missing | 0/2 (0) | 0/1 (0) | 0/0 (NA) | |
| Muscle spasms | American Indian or Alaska Native | 0/9 (0) | 0/7 (0) | 0/1 (0) |
| Asian | 0/16 (0) | 0/16 (0) | 0/8 (0) | |
| Black or African American | 3/239 (1.3) | 1/210 (0.5) | 0/110 (0) | |
| Multiple | 0/8 (0) | 0/7 (0) | 0/2 (0) | |
| Native Hawaiian or other Pacific Islander | 0/4 (0) | 0/6 (0) | 0/1 (0) | |
| Other | 0/3 (0) | 0/2 (0) | 0/2 (0) | |
| White | 8/593 (1.3) | 5/630 (0.8) | 2/314 (0.6) | |
| Missing | 0/2 (0) | 0/1 (0) | 0/0 (NA) | |
| Blood creatine phosphokinase increased | American Indian or Alaska Native | 0/9 (0) | 0/7 (0) | 0/1 (0) |
| Asian | 0/16 (0) | 0/16 (0) | 0/8 (0) | |
| Black or African American | 2/239 (0.8) | 1/210 (0.5) | 0/110 (0) | |
| Multiple | 0/8 (0) | 0/7 (0) | 0/2 (0) | |
| Native Hawaiian or other Pacific Islander | 0/4 (0) | 0/6 (0) | 0/1 (0) | |
| Other | 0/3 (0) | 0/2 (0) | 0/2 (0) | |
| White | 8/593 (1.3) | 6/630 (1.0) | 2/314 (0.6) | |
| Missing | 0/2 (0) | 0/1 (0) | 0/0 (NA) | |
| Rash | American Indian or Alaska Native | 0/9 (0) | 0/7 (0) | 0/1 (0) |
| Asian | 0/16 (0) | 0/16 (0) | 0/8 (0) | |
| Black or African American | 2/239 (0.8) | 2/210 (1.0) | 1/110 (0.9) | |
| Multiple | 1/8 (12.5) | 0/7 (0) | 0/2 (0) | |
| Native Hawaiian or other Pacific Islander | 0/4 (0) | 0/6 (0) | 0/1 (0) | |
| Other | 0/3 (0) | 0/2 (0) | 0/2 (0) | |
| White | 7/593 (1.2) | 4/630 (0.6) | 1/314 (0.3) | |
| Missing | 0/2 (0) | 0/1 (0) | 0/0 (NA) | |
Source: Clinical Trial Data
Abbreviations: AE, adverse event; HB/APAP, hydrocodone bitartrate/acetaminophen; N, number of patients in treatment arm; n, number of patients with adverse event; NA, not applicable; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
Table 7. Adverse Reactions by Age
| Characteristic | JOURNAVX N=874 n/Ns (%) | HB/APAP N=879 n/Ns (%) | Placebo N=438 n/Ns (%) | |||
|---|---|---|---|---|---|---|
| ≥18 to <65 Years | ≥65 Years | ≥18 to <65 Years | ≥65 Years | ≥18 to <65 Years | ≥65 Years | |
| Number of subjects with at least one AE | 343/827 (41.5) | 13/47 (27.7) | 439/844 (52.0) | 13/35 (37.1) | 192/415 (46.3) | 9/23 (39.1) |
| Selected adverse reactions | ||||||
| Pruritus | 17/827 (2.1) | 1/47 (2.1) | 30/844 (3.6) | 0/35 (0) | 7/415 (1.7) | 0/23 (0) |
| Muscle spasms | 11/827 (1.3) | 0/47 (0) | 6/844 (0.7) | 0/35 (0) | 1/415 (0.2) | 1/23 (4.3) |
| Blood creatine phosphokinase increased | 10/827 (1.2) | 0/47 (0) | 6/844 (0.7) | 1/35 (2.9) | 2/415 (0.5) | 0/23 (0) |
| Rash | 9/827 (1.1) | 1/47 (2.1) | 6/844 (0.7) | 0/35 (0) | 2/415 (0.5) | 0/23 (0) |
Source: Clinical Trial Data
Abbreviations: AE, adverse event; HB/APAP, hydrocodone bitartrate/acetaminophen; N, number of patients in treatment arm; n, number of patients with adverse event; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.