Original Article

(SPRIX) containing 6 % of lidocaine (ROX-828) for acute treatment of migraine: Safety and efficacy data from a phase II clinical trial V Pfaffenrath1, E Fenzl2, D Bregman3,4 and M Färkkila5 Objective: Ketorolac is a non-triptan, non-opioid, mixed cyclooxygenase (COX)1/2-inhibitor for short-term management of moderate-to-severe acute pain. This trial evaluated an intranasal formulation of ketorolac tromethamine (SPRIX) containing 6 % lidocaine (ROX-828) for the acute treatment of migraine with and without aura as defined by the International Headache Society. Methods: Patients were randomly assigned 1:1 to self-treat with intranasal ROX-828 (31.5 mg ketorolac tromethamine/ 200 mL, containing 6 % of lidocaine) or placebo (with 6 % lidocaine) within four hours of a new migraine attack ratedmoderate in pain intensity. Assessments included headache intensity and associated migraine symptoms (nausea, vomiting, phonophobia, photophobia) measured at baseline and at regular intervals through 48 hours post-dosing, and global impression of efficacy (seven-point scale) measured at two hours