Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial naproxen · 1 trial · 1 indication
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
| Arm | Type | Description |
|---|---|---|
| Test naproxen sodium tablet | EXPERIMENTAL | Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX) |
| Commercial naproxen sodium tablet | ACTIVE_COMPARATOR | Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets |
| Commercial naproxen sodium liquid gels capsule | ACTIVE_COMPARATOR | Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules |
| Placebo tablet | PLACEBO_COMPARATOR | Single dose of two Placebo tablets |
| Name | Type | Description |
|---|---|---|
| Test naproxen sodium tablet | DRUG | Single dose of 2 test naproxen sodium 220 mg tablets |
| Commercial naproxen sodium tablet | DRUG | Single dose of 2 naproxen sodium 220 mg tablets |
| Commercial naproxen sodium liquid gels capsule | DRUG | Single dose of 2 naproxen sodium 220 mg liquid gel capsules |
| Placebo tablet | DRUG | 2 placebo tablets |
Inclusion Criteria: 1. 17 - 50 years old 2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening 3. Dental extraction of three or four third molars 4. Meets post-surgical pain 5. Females of childbearing potential and males agree to contraceptive requ...
Commercial naproxen is a small molecule being studied for the treatment of post-operative dental pain. It is currently in Phase 3 clinical development as an investigational drug and has not been approved for this use.
Commercial naproxen is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ.
Commercial naproxen is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities for post-operative dental pain.
Commercial naproxen has one completed Phase 3 clinical trial, NCT03566979, which studied the efficacy and safety of a naproxen sodium 220mg tablet in postoperative dental pain. The trial enrolled 501 participants in the United States.
Commercial naproxen is not FDA approved for post-operative dental pain. It is an investigational drug currently in Phase 3 clinical development, with one completed clinical trial.
Commercial naproxen is a small molecule being studied for pain relief. Its specific molecular target has not been disclosed in the available information.