Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Celecoxib Oral Solution
DFN-15 Active · 2 trials · 1 indication
Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]) during DB1.
Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
| Arm | Type | Description |
|---|---|---|
| DFN-15 Active | EXPERIMENTAL | DFN-15 Active |
| DFN-15 Placebo | PLACEBO_COMPARATOR | DFN-15 Placebo |
| Name | Type | Description |
|---|---|---|
| DFN-15 Active | DRUG | - |
| DFN-15 Placebo | OTHER | - |
Inclusion Criteria: 1. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks. 2. Patients who have migraine with or without aura...
DFN-15 is being developed for the treatment of migraine headache. It is an investigational small molecule studied in adult patients with migraine. Collegium Pharmaceutical, Inc. is developing the asset, which has been evaluated in two completed Phase 3 clinical trials conducted in the United States.
DFN-15 is being developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. The company is the sponsor behind the clinical program evaluating the asset in migraine headache, a neurological condition. Both of the Phase 3 trials for DFN-15 were run in the United States.
DFN-15 is in Phase 3 clinical development for migraine headache. Two Phase 3 trials have been completed, and no trials are currently active. The program has enrolled a total of 1,253 participants across those two studies, which were randomized, double-blind, and placebo-controlled.
DFN-15 has been studied in two completed Phase 3 trials: NCT03009019, titled Efficacy, Tolerability, and Safety of DFN-15, which enrolled 631 participants, and NCT03006276, titled Efficacy, Tolerability, and Safety Study of DFN-15, which enrolled 622 participants. Both trials enrolled adults aged 18 years and older with migraine headache in the United States.
DFN-15 is investigational and has not been established as approved. It remains in clinical development, with two completed Phase 3 trials in migraine headache. Both studies were randomized, double-blind, and placebo-controlled, and together enrolled 1,253 participants. No trials for DFN-15 are currently active.
DFN-15 was evaluated in two completed Phase 3 trials in migraine headache, both randomized, double-blind, and placebo-controlled. NCT03009019 enrolled 631 participants and NCT03006276 enrolled 622, for a combined total of 1,253. Both studies enrolled adults 18 years and older in the United States and did not include healthy volunteers.