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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
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.
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.
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
Jean Engels (Zosano Pharma) Jean Engels has received personal compensation for serving as an employee of Zosano Pharma. Jean Engels has received stock or an ownership interest from Zosano Pharma.