To assess the safety and efficacy of two doses of an oral liquid formulation of celecoxib for acute treatment of migraine with or without aura in adults.

Celecoxib is approved in oral capsule form for the treatment of a number of episodic and chronic pain conditions.  There have been no controlled investigations of celecoxib for the treatment of migraine, in part due to its slow absorption. We have developed an oral liquid formulation of celecoxib that has demonstrated more rapid absorption. 

At 2 hours, pain free rates were 29.1% for 120 mg, 26.1% for 240 mg, and 17.6% for placebo. Overall, both doses of DFN-15 showed higher 2-hour pain free rates compared with placebo.  Results were similar with observed cases or LOCF methods for imputing missing data, but results did not reach statistical significance. At 2 hours, rates of freedom from most bothersome symptom (MBS) were 50% for 120 mg, 39.5% for 240 mg, and 28.2% for placebo.  Photophobia was most commonly identified as the MBS. No SAE related to study medication was reported. The most commonly reported AE was dysgeusia (n=6). 

A numerical separation was seen between both DFN-15 doses and placebo for 2-hour freedom from migraine pain and most bothersome symptom. No dose response was observed between DFN-15 120 mg and 240 mg. A fully powered study is underway to assess the efficacy and safety of DFN-15 120 mg dose for treatment of episodic migraine.