Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine
The Journal of Headache and Pain May 28, 2021
Nahas SJ, Hindiyeh N, Friedman DI, et al. - Researchers investigated the long-term safety and tolerability profile of M207, an investigational microneedle-based system for intracutaneous delivery of zolmitriptan, in the acute treatment of migraine. They conducted 6–12 month open-label, multicenter observational study, in which an eDiary was used by participants to record headache symptoms and adverse events at specified intervals up to 48 h following treatment of a qualifying attack with M207 3.8 mg (intracutaneous zolmitriptan). A total of 335 participants received treatment for ≥ 1 migraine attack. Of these, 257 completed 6 months and 127 completed 1 year of treatment. Cutaneous adverse reactions such as application site erythema, swelling, and bleeding were experienced by the majority of participants, and most of these reactions were scored as mild. Results were in line with what was observed in the single migraine attack treatment ZOTRIP trial indicating that M207 is well tolerated in the setting of longer-term repeated use. In addition, efficacy findings were similar to those in the ZOTRIP trial.
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