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M207, a novel microneedle-based
system for intracutaneous delivery of zolmitriptan, is linked with mild
application site effects.
Intracutaneous delivery of zolmitriptan (M207 3.8 mg) lead to mild cutaneous adverse reactions like bleeding, application site erythema, and swelling in migraine patients, a novel multicenter observational study issued in The Journal of Headache and Pain revealed. Keeping in view the encouraging outcomes of an earlier randomized-controlled phase II/III efficacy study (ZOTRIP), this current study assessed the long-term safety, efficacy and tolerability profile of M207 therapy for acute migraine.
With the aid of an eDiary, the enrolled subjects noted their headache symptoms and side effects up to 48 hours after the treatment of a qualifying attack with M207 3.8 mg (intracutaneous zolmitriptan). Clinical evaluations were done at designated intervals for about 12 months. On the whole, 257 and 127 patients completed six months and one year of therapy, respectively, out of a total of 335 participants who received treatment for ≥1 migraine attack.
A low occurrence of reported attacks after randomization was the most common reason for study withdrawal. Treatment of 5963 migraine attacks was done. Almost all the patients had a minimum of 1 adverse event (mainly mild application site reaction). Out of 14 patients who withdrew from the study, four withdrew because of application site reactions.
Subjects attained pain freedom in 44% of attacks, most bothersome symptom freedom in 62% of attacks, and pain decrease 2 hours following the dose in 81% of attacks, as shown in Figure 1:
The percentage of headaches for which participants had sustained pain freedom from two to24 hours and from two to 48 h post-dose is illustrated in Figure 2:
Along with similar efficacy outcomes, the
outcomes of this study are in line with the ZOTRIP trial implying that M207 is
well tolerated in long-term recurrent use, as concluded.
The Journal of Headache and Pain
Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine
Stephanie J Nahas et al.
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