Development of a novel zolmitriptan intracutaneous microneedle system (Qtrypta™) for the acute treatment of migraine.

M207 is an investigational intracutaneous microneedle therapeutic system for nonoral zolmitriptan delivery. In a Phase I trial, M207 provided faster absorption with a higher 2 h exposure than oral zolmitriptan. In the pivotal trial evaluating efficacy, tolerability and safety in moderate-to-severe migraine attacks, M207 3.8 mg was superior to placebo in providing freedom from headache pain (42 vs 14%) and freedom from most bothersome symptom (68 vs 43%) 2 h post-dose. Treatment-emergent adverse events were mild and transient and most commonly concerned the application site. In post hoc analyses: pain freedom was sustained in approximately 1/3 of patients; efficacy was observed in migraine headaches that are typically more difficult to treat.