JOURNAVX effectively reduced moderate-to-severe acute pain after surgerya
a Compared to placebo (sugar pill).
STUDY DESIGN
JOURNAVX was studied in 2 large clinical trials with a total of over 2000 adults with moderate-to-severe acute pain
The trials were designed to learn the possible benefits and risks of treatment with JOURNAVX compared with placebo (sugar pill) or hydrocodone bitartrate/acetaminophen, which is a combination of a commonly prescribed opioid and acetaminophen.
The primary goal of the studies was to determine how people’s pain decreased over 48 hours with JOURNAVX versus placebo.
A key secondary goal of the studies was to determine how people's pain decreased over 48 hours with JOURNAVX versus hydrocodone/acetaminophen.
JOURNAVX was studied in adults who had moderate-to-severe acute pain after full abdominoplasty (tummy tuck) or bunionectomy (bunion removal).
People randomly received either JOURNAVX, hydrocodone/acetaminophen, or a placebo (sugar pill).
Both trials included a range of people across different races, ages, and genders.c
Pain was evaluated over 48 hours, and people could take ibuprofen (400 mg every 6 hours) if they needed more pain medicine.
b In order to find out if people were a good fit for these trials, their pain was measured during a specific window after their surgery (4 hours after tummy tuck completion, and during the 9-hour period after stopping regional anesthesia following bunion removal). People who were a good fit described their pain as moderate to severe on the Verbal Categorical Rating Scale (VRS), which ranges from no pain to severe pain. They also rated their pain with a score of 4 or higher on the Numeric Pain Rating Scale (NPRS), which measures pain on a scale from 0 to 10.
c Trial 1 included 1118 people with moderate-to-severe acute pain after a tummy tuck
- The average pain score was 7.4 before treatment
- Most people were female (98%)
- The average age of people was 41, but ages ranged from 18 to 69
- 70% of people were White, 27% were Black or African American, 1% were Asian, 0.8% were Native Hawaiian or Other Pacific Islander, 0.5% were American Indian or Alaska Native, and 0.9% were Other or Multiracial participants, among which 34% identified as Hispanic or Latino
Trial 2 included 1073 people with moderate-to-severe pain after a bunion removal
- The average pain score was 6.8 before treatment
- Most people were female (85%)
- The average age of people was 48, but ages ranged from 18 to 75
- 71% of people were White, 24% were Black or African American, 2% were Asian, 0.2% were Native Hawaiian or Other Pacific Islander, 1% American Indian or Alaska Native, 1% Other or Multiracial, and 0.3% with race missing, among which 34% identified as Hispanic or Latino
Each group started with similar average pain scores and body weight at the beginning of treatment.
What is acute pain?
Acute pain is a type of pain that starts suddenly and lasts less than 3 months. It often happens because of an injury or surgery.
How is pain measured?
The Numeric Pain Rating Scale (NPRS) is a commonly used measurement in which people rate the intensity of their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Numeric Pain Rating Scale (NPRS) example
STUDY RESULTS
JOURNAVX is an oral medicine that effectively reduces moderate-to-severe acute pain
People treated with JOURNAVX had greater pain reduction than those treated with placebo (sugar pill).
This was determined by a measurement called SPID48 (time-weighted sum of the pain intensity difference over 48 hours), which tracks how pain levels change over time. Higher SPID48 values mean greater pain reduction.
JOURNAVX was not better at reducing pain than hydrocodone/acetaminophen
In Trial 1 in people who had a tummy tuck, the average pain reduction was:
118.4 points with JOURNAVX versus 70.1 with placebo
48.4
SPID48 points better with JOURNAVX versus placebo
In Trial 2 in people having a bunion removed, the average pain reduction was:
99.9 points with JOURNAVX versus 70.6 with placebo
29.3
SPID48 points better with JOURNAVX versus placebo
Pain scores over the 48 hours of treatment
The graphs below show how people's pain levels changed over time, depending on what medicine they took after a tummy tuck or bunion removal.
Average Pain Intensity Over Time for JOURNAVX, Placebo, and Hydrocodone/Acetaminophen in Trial 1
TUMMY TUCK
This graph is provided for illustrative purposes. JOURNAVX was not better at reducing pain than hydrocodone/acetaminophen.
Average Pain Intensity Over Time for JOURNAVX, Placebo, and Hydrocodone/Acetaminophen in Trial 2
BUNION REMOVAL
This graph is provided for illustrative purposes. JOURNAVX was not better at reducing pain than hydrocodone/acetaminophen.
START THE CONVERSATION
If you have questions about JOURNAVX clinical study results, talk to your doctor.
What is JOURNAVX?
JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain.
It is not known if JOURNAVX is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take JOURNAVX if you take certain medicines that are strong inhibitors of an enzyme called CYP3A. Ask your healthcare provider if you are not sure.
Before taking JOURNAVX, tell your healthcare provider about all of your medical conditions, including if you:
What is JOURNAVX?
JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain.
It is not known if JOURNAVX is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take JOURNAVX if you take certain medicines that are strong inhibitors of an enzyme called CYP3A. Ask your healthcare provider if you are not sure.
Before taking JOURNAVX, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX
- are pregnant or plan to become pregnant. It is not known if JOURNAVX will harm your unborn baby. You and your healthcare provider should decide if you will take JOURNAVX while you are pregnant
- are breastfeeding or planning to breastfeed. It is not known if JOURNAVX passes into your breast milk. You and your healthcare provider should decide if you will take JOURNAVX while you are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase your risk of side effects. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Especially tell your healthcare provider if you take:
- hormonal birth control medicine (contraceptives) containing progestins other than levonorgestrel or norethindrone. If you take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. You should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after you stop taking JOURNAVX
- medicines that are substrates of the CYP3A enzyme as they may become less effective during treatment with JOURNAVX. Your healthcare provider may need to adjust the dose of your medicine when starting or stopping JOURNAVX
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking JOURNAVX?
Do not take food or drink containing grapefruit during treatment with JOURNAVX.
What are the possible side effects of JOURNAVX?
The most common side effects for patients treated with JOURNAVX included itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Talk to your healthcare provider if you have concerns about becoming pregnant. If you are using contraceptives, you should continue to use contraceptives during treatment with JOURNAVX.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of JOURNAVX.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information, for JOURNAVX.