Oral Solution of Celecoxib May Provide Migraine Relief as Early as 1 Hour 

Post-hoc analysis of pooled data from pivotal trials (NCT03009019, NCT03006276) of a novel self-emulsifying oral celecoxib solution (Elyxyb; Biodelivery Sciences International, Stoughton, MA) show that it is safe and effective for acute treatment of migraine. This formulation of celecoxib reaches maximal dose (Tmax) at 42 minutes for potentially faster acute treatment of migraine.  

Pain freedom at 2 hours occurred in 34.4% of those who treated a migraine attack at onset with this formulation of celecoxib vs 24% with placebo (P=.0002; modified intent-to-treat analysis). Freedom from most bothersome system (chosen from photophobia, phonophobia, nausea/vomiting) with oral celecoxib vs placebo was 57.3% vs 43.7% (P=.0001).  

Treatment efficacy with oral celecoxib was seen as early as 1 hour in 18.2% of participants treated with oral celecoxib vs 12.5% with placebo (P=.001). Freedom from most bothersome symptom occurred in 28.7% vs 22.4% (P=.023) at 45 minutes with celecoxib vs placebo. There was a statistically significant higher likelihood of pain freedom and freedom from most bothersome symptom with oral celecoxib vs placebo 45 minutes after dosing. 

Participants were adults, age 18 to 75 who had episodic migraine without aura (2-8 attacks/month) for at least 1 year with a minimum of 48 hours between attacks.  

The most commonly reported treatment-emergent adverse events were dysgeusia (4.2% vs 1.7%) and nausea (3.2% vs 1.4%).