Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial acetaminophen · 1 trial · 1 indication
Minutes until confirmed perceptible pain relief is 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 perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
| Arm | Type | Description |
|---|---|---|
| Test acetaminophen | EXPERIMENTAL | Test acetaminophen 1000 mg dose |
| Commercial acetaminophen | ACTIVE_COMPARATOR | Commercial acetaminophen 1000 mg dose |
| Commercial ibuprofen | ACTIVE_COMPARATOR | Commercial ibuprofen, 400 mg dose |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Test acetaminophen | DRUG | single dose of 2 Test acetaminophen 500 mg tablets |
| Commercial acetaminophen | DRUG | single dose of 2 acetaminophen 500 mg caplets |
| Commercial ibuprofen | DRUG | Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules |
| Placebo | DRUG | 2 placebo caplets |
Inclusion Criteria: 1. 17 to 50 years old 2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive) 3. Dental extraction of three or four third molars 4. Meets post-surgical pain criteria 5. Females of childbearing age must be willing to use acceptable method of birth co...
Commercial acetaminophen is used for the treatment of post-operative dental pain. It is a small molecule being developed by Johnson & Johnson for this indication. The drug has completed a Phase 3 clinical trial in this setting.
Commercial acetaminophen is developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is being studied for post-operative dental pain and has completed a Phase 3 clinical trial.
Commercial acetaminophen is in Phase 3 clinical development. It is an investigational drug for post-operative dental pain, and its Phase 3 trial has been completed. The drug is not yet approved and remains under clinical investigation.
Commercial acetaminophen has one completed Phase 3 trial, NCT03224403. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a single dose of the drug in 664 patients with post-operative dental pain in the United States.
Commercial acetaminophen is not FDA approved. It is an investigational drug in Phase 3 clinical development for post-operative dental pain. Its Phase 3 trial has been completed, but approval status has not been established.