Consistency of the Efficacy of Single Use and Repeated Use of M207 (Intracutaneous Microneedle Zolmitriptan) for the Acute Treatment of Migraine; Results for Pain Freedom, Pain Relief, and Sustained Pain Freedom and Pain Relief

Egilius L. Spierings, MD, PhD

AHSAM 2020 - Oral session
Published on October 2, 2020 | NEW

3 minute listen

7 minute read

Key messages

  • The positive results from the phase 2b/3 single dose ZOTRIP trial were also seen in a long-term repeated-use study of M207 over 12 months.
  • M207 provided 44% pain freedom and 81% pain relief from migraine at 2 hours with repeated use, similar to the results reported in the ZOTRIP trial.
  • The pattern of adverse events (AEs) was similar to the ZOTRIP trial; nearly all mild and the most common were redness and swelling at the application site.
  • Background

    What do we already know about this topic?
  • Findings

    What does this study add?
  • Perspectives

    How does this study impact clinical practice?
  • Expert commentary

    by Morris Levin, MD

Key messages

  • The positive results from the phase 2b/3 single dose ZOTRIP trial were also seen in a long-term repeated-use study of M207 over 12 months.
  • M207 provided 44% pain freedom and 81% pain relief from migraine at 2 hours with repeated use, similar to the results reported in the ZOTRIP trial.
  • The pattern of adverse events (AEs) was similar to the ZOTRIP trial; nearly all mild and the most common were redness and swelling at the application site.

Background

What do we already know about this topic?

  • M207 is a zolmitriptan intracutaneous microneedle system currently under FDA review for the acute treatment of adult migraine with or without aura.
  • In the single dose ZOTRIP trial, M207 3.8 mg, met co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours.1

How was this study conducted?

  • Longitudinal, multicenter, open-label safety study on adult patients with episodic migraine (n=342) over 12-months.
  • Patients self-administered M207 3.8 mg to treat multiple qualifying migraine headaches.
  • Co-primary endpoints were pain relief, pain freedom and MBS freedom at 2 hours, 2–24 hours and 24–48 hours post dose.
  • The results could be compared with the ZOTRIP trial because the two studies shared variables: 3.8 mg dose, identical questions in the e-Diary, pain score rated on the same scale, MBS designation, common time points and post-hoc analysis.
  • Unlike the ZOTRIP trial, the long-term study allowed treatment of mild migraine headaches, there was no placebo and proportion rates were based on all 5,617 migraine headaches treated with responses at 30 min, 2, 12, 24 and 48 hours.

Findings

What does this study add?

  • Pain freedom was achieved in 44% of migraine headaches and freedom from MBS in 62%.
  • Results were similar to those reported in the ZOTRIP trial: both trials exceeded 40% in pain freedom at 2 hours.
  • At 2–24 hours both trials’ sustained pain freedom rates exceeded 30%.
  • The pattern of adverse events (AEs) was similar to the ZOTRIP trial; nearly all mild and the most common were redness and swelling at the application site.

Perspectives

How does this study impact clinical practice?

  • For M207, results from the ZOTRIP trial were repeated with long-term use over 12 months of repeat treatment.
  • These results add to our understanding on the long-term efficacy and safety of intracutaneous zolmitriptan.

Perspectives

How does this study impact clinical practice?

  • For M207, results from the ZOTRIP trial were repeated with long-term use over 12 months of repeat treatment.
  • These results add to our understanding on the long-term efficacy and safety of intracutaneous zolmitriptan.

This is a highlights summary of an oral session given at the AHSAM 2020 Virtual Annual Scientific Meeting and presented by:

Egilius L. Spierings, MD, PhD
Medical Director
Boston Headache Institute
Waltham, Massachusetts

The content is produced by Infomedica, the official reporting partner of ASHAM 2020 Virtual Annual Scientific Meeting. The summary text was drafted by Goldcrest Medical Writing, reviewed by Marco Vercellino, MD, an independent external expert, and approved by Jessica Ailani, MD, FAHS and Mark J. Burish, MD, PhD, the scientific editors of the program.

The presenting authors of the original session had no part in the creation of this conference highlights summary.

In addition, an expert commentary on the topic has been provided by:

Morris Levin, MD
UCSF Department of Neurology

Morris Levin, MD
UCSF Department of Neurology

Dr Levin is Professor of Neurology at the University of California, San Francisco, where he directs the UCSF Headache Center.  He is also actively involved in research and teaching activities at UCSF.  He is board certified in Neurology with special qualification in Pain Medicine (ABPN).  Dr Levin is also board certified in Headache Medicine (UCNS).

Dr Levin authored a number of medical journal articles and textbook chapters in the areas of headache and pain.  He is the author of Neurology Clinical Case Studies (Anadem 2003), Comprehensive Review of Headache Medicine (Oxford University Press 2008) and Emergency Neurology (Oxford University Press 2013). He is the co-author of Head, Neck and Facial Pain (Anadem 2006), Educational Review Manual in Neurology (Castle Connolly 2006), Headache and Facial Pain (Oxford University Press 2009) and Refractory Migraine (Oxford University Press 2010). He is also the co-author of “Understanding Your Migraines” (Oxford University Press 2017), written primarily for patients and families.

He is an active member of the American Headache Society, where he is on the Board of Directors, and the International Headache Society, where he is chair of the Ethics Committee. He is also a member of the HCOP Board of directors.  He is a Fellow of the AAN, AHS and ANA.

Particular academic interests of Dr Levin include Secondary Headaches, Professional Medical Ethics, and Education in Neurology, Headache Medicine and Pain Medicine. 

1. Spierings EL, Brandes JL, Kudrow DB, et al. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalagia 2018; 38(2):215-224.



Headache
Migraine


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