LOS ANGELES — A new zolmitriptan intracutaneous system (M207) was found to be well tolerated and effective for relieving both pain and headache-associated symptoms, according to research presented at the 70th annual American Academy of Neurology meeting, held April 21-27, 2018, in Los Angeles, California.
The study tested and compared the tolerability and efficacy of Zosano Pharma’s new rapid absorption microneedle array M207 in a randomized, placebo-controlled, double-blind, dose-ranging trial in adults with migraine headaches. Subjects of similar demographics first identified their most bothersome headache-associated symptoms — such as phonophobia, nausea, and photophobia — and then entered a 28-day run-in period, during which they recorded the number of migraines experienced.
The 321 subjects with 2 to 8 migraines experienced during this time were randomly assigned to 1 of 4 groups: zolmitriptan at 1 mg, 1.9 mg, or 3.8 mg, or placebo. Participants treated a subsequent qualifying migraine according to their assigned group; they then recorded application site appearance and migraine symptoms for the next 48 hours.
At 2 hours, 41.5% were pain free in the 3.8-mg group, 27.7% were pain free in the 1.9-mg group, and 30.4% were pain free in the 1-mg group (P=.0001, P=.0351, and P=.0149 v placebo, respectively); 14.3% of those in the placebo group reported being pain free at 2 hours.
The percentages of subjects who reported relief from their most bothersome symptom at 2 hours were 68.3% for the 3.8-mg group, 53.0% for the 1.9-mg group, and 57.0% for 1-mg group (P=.0706, P=.0009, and P=.1694 vs placebo, respectively); 42.9% of subjects in the placebo group reported relief from their most bothersome symptom at 2 hours.
Two to 24 hours postdose, sustained pain freedom was reported for 31.7% of the 3.8-mg group vs 10.4% for those receiving placebo (P=.0010). Two to 48 hours postdose, 26.8% of the 3.8-mg group reported sustained pain freedom vs 9.1% for those receiving placebo (P=.0035).
Overall, M207 was well tolerated among participants, with mild redness and bruising at application site being the most common adverse event (6.3% to 26.5%), followed by dizziness (4.8% of those in the 3.8-mg group).
The study investigators concluded that “M207 3.8mg was well-tolerated and effective at relieving pain and associated [most bothersome symptom] of migraine.”
The authors report being employed by MedVadis Research and Zosano Pharma.
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Spierings E, Kellerman D, Schmidt P. Effectiveness and safety of a new zolmitriptan rapid absorption microneedle array (M207) for the acute treatment of migraine (The ZOTRIP Study). Poster presented at: 2018 AAN Annual Meeting; April 21-27, 2018; Los Angeles, CA. Poster 125.
This article originally appeared on Neurology Advisor