Approval Probability
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Adjusted LOA
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DFN-15 · 2 trials · 2 indications
The primary endpoint is the Summed Pain Intensity Difference over the first 6 hours (SPID6) after dosing compared between DFN-15 and placebo. Pain intensity (P) will be measured at timepoints of 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5 and 6, hours after baseline ,using 11-point Pain Intensity Numerical Rating Scale (NPRS). Zero (0) equals no pain and Ten (10) equals worst pain imaginable. SPID6 is created by summing the time weighted pain intensity differences (PID) scores using the area under the PID curve methodology. All SPID calculations will be performed using the standard trapezoidal rule SPIDx =∑\_(i=0)\^x▒((〖PID〗\_i+〖PID〗\_(i+1))/2) \* (T\_(i+1)- T\_i ) Where: PID\_i = P\_i - PBL (Pain score at time i and Pain score at Baseline), and (T\_i+1 - T\_i) is the Time difference in minutes between time i and time i+1. Therefore, SPID6 values may theoretically range between a maximum score of 0 ( no improvement) and a minimum score of -3525 (best improvement)
| Arm | Type | Description |
|---|---|---|
| DFN-15 (Celecoxib Oral Solution) 62.5 mg | EXPERIMENTAL | Single dose containing 62.5 mg of celecoxib in 10 ml solution |
| DFN-15 (Celecoxib Oral Solution) 125 mg | EXPERIMENTAL | Single dose containing 125 mg of celecoxib in 10 ml solution |
| DFN-15 (Celecoxib Oral Solution) 250 mg | EXPERIMENTAL | Single dose containing 250 mg of celecoxib in 10 ml solution |
| Placebo | PLACEBO_COMPARATOR | Single dose containing 0 mg of celecoxib in 10 ml solution |
| DFN-15 (fasted) | EXPERIMENTAL | - |
| DFN-15 (fed) | EXPERIMENTAL | - |
| Comparator (fed) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DFN-15 (Celecoxib Oral Solution) 62.5 mg | DRUG | Oral Solution |
| DFN-15 (Celecoxib Oral Solution) 125 mg | DRUG | Oral Solution |
| DFN-15 (Celecoxib Oral Solution) 250 mg | DRUG | Oral Solution |
| Placebo | DRUG | Oral Solution |
| DFN-15 (fasted) | DRUG | DFN-15 administered to fasted subjects |
| DFN-15 (fed) | DRUG | DFN-15 administered to fed subjects |
| Comparator Celebrex® (fed) | DRUG | Comparator (Celebrex®) administered to fed subjects |
Inclusion Criteria: 1. Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia. 2. Subjects must be generally healthy, ambulatory, able to understand and willing to comply with study procedures, study restrictions, assessments, and requireme...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
DFN-15 is an investigational small molecule being developed for the treatment of acute pain and migraine. It is currently in Phase 2 clinical development and has not been approved by the FDA.
DFN-15 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol RDY.
DFN-15 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials have been completed for both Phase 1 and Phase 2 studies.
DFN-15 has been studied in two completed clinical trials. NCT03282838 was a Phase 1 study of pharmacokinetics in healthy adults with migraine. NCT03554772 was a Phase 2 efficacy, tolerability, safety, and pharmacokinetic study in patients with acute pain.
DFN-15 is an investigational drug candidate developed by Dr. Reddy's Laboratories. It is being studied for acute pain and migraine, and no alternative names have been reported in clinical trial registries.