Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial ACE · 1 trial · 1 indication
Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain
| Arm | Type | Description |
|---|---|---|
| Test Acetaminophen (ACE) (1000 mg) and placebo | EXPERIMENTAL | - |
| Commerical ACE (1000 mg) and placebo | ACTIVE_COMPARATOR | - |
| Commerical Ibuprofen (IBU) (400 mg) and placebo | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acetaminophen (ACE) (1000 mg) | DRUG | 2 Test ACE 500 mg tablets taken orally one time |
| Commercial ACE (1000 mg) | DRUG | 2 ACE 500 mg caplets taken orally one time |
| Commercial Ibuprofen (IBU) (400 mg) | DRUG | 2 IBU 200 mg soft-gels taken orally one time |
| Placebo | DRUG | 2 placebo caplets for acetaminophen taken orally one time |
Inclusion Criteria: 1. Are 17 to 50 years of age 2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive) 3. Dental extraction of three or four third-molars. 4. Experience moderate to severe pain after extraction of third molars Exclusion Criteria: 1. Currently pregnant (or plan...
Commercial ACE is being studied for the treatment of dental pain. It is an investigational small molecule developed by Johnson & Johnson for pain management, specifically evaluated in a post-operative dental pain setting. It has not been approved for any indication and remains in clinical development.
Commercial ACE is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor behind the clinical program evaluating this small molecule in dental pain.
Commercial ACE is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for any indication.
Commercial ACE has been evaluated in one completed Phase 2 trial, NCT02320708, titled Study of Acetaminophen (ACE) in Post-operative Dental Pain. The trial enrolled 240 participants in the United States, was randomized, double-blind, and placebo-controlled, and included patients aged 17 years and older.