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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Align Technology, Inc. | ALGN | 2 | N/A | Undisclosed |
| Solventum Corporation | SOLV | 1 | N/A | Undisclosed |
| Haleon PLC Sponsored ADR | HLN | 1 | N/A | Undisclosed |
| DENTSPLY SIRONA, Inc. | XRAY | 1 | N/A | Undisclosed |
| Envista Holdings Corp. | NVST | 2 | - | Undisclosed |
| Smith & Nephew plc Sponsored ADR | SNN | 1 | - | Undisclosed |
Commercial ACE is an investigational small molecule being studied for the treatment of dental pain. It is currently in Phase 2 clinical development and has not been approved by the FDA. A completed Phase 2 trial evaluated its use in post-operative dental pain.
Commercial ACE is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for dental pain.
Commercial ACE is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial for dental pain has been completed.
Commercial ACE has one completed Phase 2 clinical trial, identified as NCT02320708. This study, titled 'Study of Acetaminophen (ACE) in Post-operative Dental Pain,' enrolled 240 participants in the United States and was placebo-controlled, randomized, and double-blind.
Commercial ACE is also known as acetaminophen, a common pain reliever. In the clinical trial context, it is being studied as a small molecule for dental pain. The drug is being developed by Johnson & Johnson and is currently in Phase 2 development.