Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DFN-15 Dose 1
DFN-15 · 3 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)
Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration
| 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-15 120 mg (treatment A) | EXPERIMENTAL | DFN-15 120 mg (treatment A) |
| DFN-15 240 mg (treatment B) | EXPERIMENTAL | DFN-15 240 mg (treatment B) |
| Placebo (treatment C) | PLACEBO_COMPARATOR | Placebo (treatment C) |
| 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 Dose A (treatment A) | DRUG | DFN-15 Dose A administered |
| DFN-15 Dose B (treatment B) | DRUG | DFN-15 Dose B administered |
| Placebo (treatment C) | OTHER | Placebo administered |
| 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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
DFN-15 is an investigational small molecule drug being developed by Dr. Reddy's Laboratories Ltd for the treatment of acute pain and migraine. It is a celecoxib oral solution and is also referred to as DFN-15 Dose 1, DFN-15 Dose A, and DFN-15 (Celecoxib Oral Solution) 62.5 mg. It remains in clinical development.
DFN-15 is being studied for acute pain and migraine. Clinical trials have evaluated it in patients with acute pain and in patients with migraine headaches. It is an investigational therapy and has not been established as a treatment option outside of clinical research.
DFN-15 is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company has sponsored the clinical trials evaluating DFN-15 in acute pain and migraine, including a Phase 2 efficacy and safety study and a Phase 1 pharmacokinetic study.
DFN-15 is in Phase 2 clinical development. Two completed Phase 2 trials have evaluated it in acute pain and migraine, and a completed Phase 1 pharmacokinetic study has also been conducted. It is investigational and has not been approved by the FDA.
DFN-15 has been evaluated in completed trials including NCT03554772, a Phase 2 efficacy, tolerability, safety, and pharmacokinetic study in acute pain with 120 participants, NCT03282838, a Phase 1 pharmacokinetic and food-effect study in healthy adults, and NCT02472418, a Phase 2 study of two dose levels versus placebo in migraine.
Yes, DFN-15 is a celecoxib oral solution. It is also known by the names DFN-15 Dose 1, DFN-15 Dose A, DFN-15 (fasted), and DFN-15 (Celecoxib Oral Solution) 62.5 mg. These names refer to the same investigational drug candidate developed by Dr. Reddy's Laboratories Ltd.