Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 Active is an investigational small molecule being developed for the treatment of migraine headache. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in adult patients in the United States.
DFN-15 Active is being developed by Collegium Pharmaceutical, Inc., a company traded on the NASDAQ under the ticker symbol COLL. The company is conducting Phase 3 clinical trials for this investigational migraine treatment.
DFN-15 Active is in Phase 3 clinical development for migraine headache. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been completed, but the drug remains in clinical development.
DFN-15 Active has been studied in two completed Phase 3 clinical trials: NCT03006276 and NCT03009019. Both trials evaluated the efficacy, tolerability, and safety of DFN-15 in patients with migraine headache, with a combined enrollment of 1,253 participants.
DFN-15 Active is the name used in the clinical trial data for the drug also referred to as DFN-15. Both names refer to the same investigational small molecule being developed by Collegium Pharmaceutical for migraine headache.