Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-10450232/ Not yet marketed · 1 trial · 1 indication
Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).
| Arm | Type | Description |
|---|---|---|
| JNJ-10450232 250 mg | EXPERIMENTAL | - |
| JNJ-10450232 1000 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Acetaminophen 1000 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNJ-10450232 / Not yet marketed | DRUG | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
| acetaminophen / Tylenol | DRUG | Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. |
Inclusion Criteria: * Subjects aged 18-45 years * At least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (PI-NRS) following surgical removal of three third-molars Exclusion Criteria: ...
JNJ-10450232 is an investigational small molecule pain reliever being developed by Johnson & Johnson. It has been studied in a Phase 2 dental pain trial but is not yet marketed. It is designed as a new treatment option for pain and remains in clinical development.
JNJ-10450232 is being studied for the treatment of pain. Its only reported clinical trial enrolled 269 adults with dental pain in the United States. The drug is investigational and has not been approved for any indication.
Johnson & Johnson, which trades under the ticker JNJ, is developing JNJ-10450232. The company sponsored the Phase 2 dental pain study of the compound. No partnership or licensing arrangement for the asset has been announced.
JNJ-10450232 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any use.
JNJ-10450232 has been evaluated in one completed Phase 2 trial, NCT02209181, titled a dental pain study to test the effectiveness of a new pain reliever medicine. The randomized, double-blind, placebo-controlled study enrolled 269 male participants aged 18 and older in the United States.
JNJ-10450232 is also referred to by the same code name, JNJ-10450232, and has no separate brand name because it is not yet marketed. Searches for the compound under that identifier refer to the same Johnson & Johnson investigational pain candidate.