NeurAxon reports encouraging results from Phase II migraine trial

In the study, patients experiencing migraine with aura achieved sustained relief from their headaches, representing a potentially differentiated treatment profile from current migraine therapies.

Data from the Phase II trial showed that patients receiving NXN-188 experienced a 15% greater effect than placebo in migraine pain relief at two hours, which did not meet the primary endpoint of the trial. In the secondary endpoint analyses, patients receiving NXN-188 experienced a 32% and 35% greater effect than placebo at four hours and six hours, respectively.

A post hoc analysis of patients with a history of aura, representing 47% of all patients in the study, demonstrated statistically significantly sustained pain relief for up to 24 hours without rebound headache. Approximately 22%, 48% and 68% of patients with aura experienced relief compared to placebo at two hours, four hours and six hours, respectively.

These data, if prospectively validated, would represent a 30% increase in sustained pain relief at the 100mg dose compared to sumatriptan. In all 219 unique subjects dosed to date, NXN-188 has been well tolerated, and there have been no reported serious adverse events. Based on these robust data, NeurAxon is planning a Phase II trial of NXN-188 in migraineurs with aura to confirm the activity observed in the Phase II trial.

The NXN-188 Phase II trial was a randomized, multi-center, double-blind, placebo-controlled parallel-group Phase II trial of NXN-188 in patients with migraine. Approximately 60 patients aged 18-65 who met International Headache Society criteria for migraine received one of three doses of NXN-188 or placebo in the study.