The placebo-controlled proof of concept study evaluated the efficacy and safety of ROX-828, an intranasal formulation of the non-steroidal anti-inflammatory pain reliever ketorolac. The trial which was conducted at 17 sites in Germany and Finland, involved 68 patients who received ROX-828 and 72 patients who received placebo. The study was conducted on an out-patient basis, with participants instructed to self-administer one dose of study drug when they experienced a migraine attack.
In the study, patients reported their pain levels at baseline and at regular intervals (0.5, one, 1.5, two, three, four, 24, and 48 hours) and those treated with ROX-828 showed a statistically significant improvement in pain relief at all time points except 0.5 and 24 hours compared with those who received placebo.
Statistically more patients achieved pain-free status with ROX-828 than placebo at 1.5, three, four, 24 and 48 hours. At two hours following dosing, a self-reported measurement tool (the Patients’ Global Impression of Study Efficacy) showed statistically better results for patients receiving ROX-828 than placebo. Associated migraine symptoms, including nausea and vomiting, also showed statistically significant improvement when ROX-828 was compared to placebo at several time points throughout the observation period. ROX-828 was generally well-tolerated, with no difference in overall adverse events between the ROX-828 and the placebo groups.
Roxro is also developing ROX-888, a different investigational intranasal formulation of ketorolac, for the treatment of moderate-to-severe acute pain, such as post-operative pain. The Phase III clinical program for ROX-888 is completed, and Roxro anticipates submitting a new drug application with the FDA later this year. If approved, ROX-888 would be the first non-opioid intranasal analgesic indicated for the treatment of moderate-to-severe acute pain.