New Zolmitriptan Intracutaneous System Safe and Effective for Migraine
Adults with migraine were instructed to identify their most problematic headache-associated symptom.
|The following article is part of conference coverage from the 2018 American Academy of Neurology Annual Meeting in Los Angeles, California. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2018.|
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.