OBJECTIVE: To determine the long-term safety and tolerability profile of M207 in the acute treatment of migraine.BACKGROUND: M207 is an investigational microneedle-based system for intracutaneous delivery of zolmitriptan for the treatment of migraine attacks. Following on the positive results of a Phase 2/3 placebo-controlled efficacy study (ZOTRIP), this study was designed to evaluate the safety of this novel product during repeated use for the treatment of migraine attacks.METHODS: In this 6-12month open-label, multicenter observational study, participants used an eDiary to record headache symptoms and adverse events at specified intervals up to 48h following treatment of a qualifying attack with M207 3.8mg (intracutaneous zolmitriptan). Participants underwent clinical evaluations at specified intervals up to 12months.RESULTS: Among 335 participants who treated =1 migraine attack, 257 completed 6months and 127 completed 1year of treatment. The most common reason for withdrawal from the study was a low frequency of reported attacks post randomization. Overall, 5963 migraine attacks were treated. Most participants (96%) experienced at least 1 adverse event, the vast majority of which concerned the application site, and>95% of which were mild. Fifteen participants (4%) withdrew due to adverse events; 4 withdrew due to 7 application site reactions, 6 of which were mild. Participants achieved pain freedom in 2477/5617 (44%) of attacks, most bothersome symptom freedom in 3315/5330 (62%) of attacks, and pain relief 2h post-dose in 4552/5617 (81%) of attacks. Sustained pain freedom 2-24h was seen in 1761/4698 (38%) of attacks, and 2-48h in 1534/4429 (35%) of attacks.CONCLUSIONS: The majority of participants experienced cutaneous adverse reactions such as application site erythema, swelling, and bleeding, and most reactions were scored as mild. These results are consistent 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. Efficacy findings were also similar to those in the ZOTRIP trial.TRIAL REGISTRATION: Clinicaltrials.gov on September 13, 2017 ( NCT03282227 ).
View details for DOI 10.1186/s10194-021-01249-z
View details for PubMedID 34001002