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Abstract Details

Comparison of Efficacy Outcomes in Trials Using a M207 in the Acute Treatment of a Single Migraine or Multiple Migraines
Headache
Headache Posters (7:00 AM-5:00 PM)
043
To determine whether efficacy outcomes from the pivotal single-dose, placebo-controlled, ZOTRIP trial were replicated in a subsequent trial using M207 (intracutaneous microneedle zolmitriptan) repeatedly over the course of a year for the acute treatment of migraine.
The ZOTRIP trial met its co-primary endpoints with a significantly higher percentage of participants in the M207 3.8 mg group achieving pain freedom (PF)  and freedom from most bothersome other symptom at 2 hours compared with placebo (PBO).  These endpoints and other efficacy endpoints were also evaluated in a 6-12 month multicenter, open-label study.
In the open-label study, participants used an eDiary to record headache symptoms and adverse events at specified intervals out to 48 hours following treatment of a qualifying attack with M207 3.8 mg. Questions and rating scales for migraine pain and related symptoms were identical to those in ZOTRIP.  

In the open-label, 335 participants treated a total of 5617 attacks and had 2-hour pain scores.  PF at 2 hours was achieved in 44% of attacks compared with 42% in the M207 3.8 mg group and 14% in the PBO group from the ZOTRIP trial. Corresponding values for pain relief (PR) were 81%, 81%, and 57%. Sustained PF (2-24 hours) was observed in 38% versus 32% (M207) and 10% (PBO) in ZOTRIP. Sustained PF (2-48 hours) values were 35% versus 27% (M207) and 9% (PBO) in ZOTRIP. Sustained PR (2-24 hours) was seen in 70% compared with 68% (M207) and 38% (PBO) in ZOTRIP. Sustained PR (2-48 hours) occurred in 65%, 63%, and 33%, respectively.
Response rates were similar between the single-dose trial and the long-term extension. Together, these results suggest that approximately 43% pain freedom and 81% pain relief at 2 hours are good estimates of M207 efficacy over time.
Authors/Disclosures
Donald Kellerman (Zosano)
PRESENTER 		No disclosure on file
No disclosure on file