Intranasal ketorolac tromethamine (SPRIX) containing 6% of lidocaine (ROX-828) for acute treatment of migraine: Safety and efficacy data from a phase II clinical trial
Pfaffenrath V et al. – Self–administered intranasal ROX–828 was well tolerated. While the primary endpoint was not met, the results provide preliminary evidence that ROX–828 improves migraine pain.Methods
- Patients were randomly assigned 1:1 to self–treat with intranasal ROX–828 (31.5mg ketorolac tromethamine/200μL, containing 6% of lidocaine) or placebo (with 6% lidocaine) within four hours of a new migraine attack rated≥moderate 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.
- Randomized patients who had a migraine attack (N=140) were evaluable (ROX–828, N=68; placebo, N=72).
- Patients receiving ROX–828 showed a significant (p<0.05) improvement in pain relief at all time points except 0.5 and 24 hours compared with those who received placebo.
- More patients achieved pain–free status with ROX–828 than with placebo at 1.5, 3, 4, 24 and 48 hours (p<0.05); significance at the two–hour time point, which was the primary endpoint, was not met.
- Patients’ global impression of efficacy showed statistically significantly better results for patients receiving ROX–828 than for those receiving placebo.