Background
What do we already know about this topic?
- M207 is a zolmitriptan intracutaneous microneedle system currently under FDA review for the acute treatment of adult migraine with or without aura.
- In the single dose ZOTRIP trial, M207 3.8 mg, met co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours.1
How was this study conducted?
- Longitudinal, multicenter, open-label safety study on adult patients with episodic migraine (n=342) over 12-months.
- Patients self-administered M207 3.8 mg to treat multiple qualifying migraine headaches.
- Co-primary endpoints were pain relief, pain freedom and MBS freedom at 2 hours, 2–24 hours and 24–48 hours post dose.
- The results could be compared with the ZOTRIP trial because the two studies shared variables: 3.8 mg dose, identical questions in the e-Diary, pain score rated on the same scale, MBS designation, common time points and post-hoc analysis.
- Unlike the ZOTRIP trial, the long-term study allowed treatment of mild migraine headaches, there was no placebo and proportion rates were based on all 5,617 migraine headaches treated with responses at 30 min, 2, 12, 24 and 48 hours.