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IBU · 2 trials · 1 indication
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 \[0-24\]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).
| Arm | Type | Description |
|---|---|---|
| Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg | ACTIVE_COMPARATOR | FDC IBU/APAP 250 mg/500 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Ibuprofen 5% topical gel BID | EXPERIMENTAL | IBU BID (Treatment A) |
| Placebo topical gel BID | PLACEBO_COMPARATOR | Placebo BID (Treatment B) |
| Ibuprofen 5% topical gel TID | EXPERIMENTAL | IBU TID (Treatment C) |
| Placebo topical gel TID | PLACEBO_COMPARATOR | Placebo TID (Treatment D) |
| Name | Type | Description |
|---|---|---|
| FDC IBU/APAP 250 mg/500 mg | DRUG | FDC IBU/APAP 250 mg/500 mg |
| Placebo | DRUG | Placebo |
| IBU BID | DRUG | 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days |
| Placebo BID | DRUG | 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days |
| IBU TID | DRUG | 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days |
| Placebo TID | DRUG | 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days |
Inclusion Criteria 1. Males and females 18 years to 40 years of age (inclusive). 2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction. 3. Subject must have at least moderate pain on the 4 point c...
IBU is a small molecule drug being developed by Pfizer, Inc. for the treatment of pain. It is currently in Phase 3 clinical development. IBU has been studied in clinical trials for pain conditions, including delayed onset muscle soreness and post-surgical dental pain.
IBU is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for the treatment of pain.
IBU is in Phase 3 clinical development. It has completed two Phase 3 trials, with a total enrollment of 328 participants. Both trials were randomized, double-blind, and placebo-controlled, and neither is currently active.
IBU has completed two Phase 3 clinical trials. The first, NCT01794923, studied topical ibuprofen for delayed onset muscle soreness with 205 participants. The second, NCT02837952, studied ibuprofen 250mg combined with APAP 500mg for post-surgical dental pain with 123 participants.
IBU is an investigational drug and has not been approved by the FDA. It is currently in Phase 3 clinical development for the treatment of pain. The completed clinical trials have not led to regulatory approval, and the drug remains under investigation.