Development of a Novel Zolmitriptan Intracutaneous Microneedle System (Qtrypta™) for the Acute Treatment of Migraine

Abstract

M207 is an investigational intracutaneous microneedle therapeutic system for nonoral zolmitriptan delivery. In a Phase I trial, M207 provided faster absorption with a higher 2 h exposure than oral zolmitriptan. In the pivotal trial evaluating efficacy, tolerability and safety in moderate-to-severe migraine attacks, M207 3.8 mg was superior to placebo in providing freedom from headache pain (42 vs 14%) and freedom from most bothersome symptom (68 vs 43%) 2 h post-dose. Treatment-emergent adverse events were mild and transient and most commonly concerned the application site. In post hoc analyses: pain freedom was sustained in approximately 1/3 of patients; efficacy was observed in migraine headaches that are typically more difficult to treat.

Keywords::

• drug delivery
• headache
• intracutaneous
• M207
• migraine
• triptan
• zolmitriptan

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2020-0041

Author contributions

M Ameri, H Lewis, DJ Kellerman contributed to design of studies, acquisition and interpretation of data, and critical review of the manuscript. AM Rapoport contributed to design of studies, interpretation of data and critical review of the manuscript. All authors provided final approval for publication.

Financial & competing interests disclosure

AM Rapoport serves as an advisor for Allergan, Amgen, Amneal, Biohaven, Cala Health, Impel, Novartis, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc and Zosano; AM Rapoport is also on the speaker bureau of Allergan, Amgen, Biohaven, Lundbeck and Teva Pharmaceutical Industries. M Ameri, H Lewis, DJ Kellerman are employees of Zosano Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing support was provided by P Foreman, and funded by Zosano Pharma.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

Deidentified individual participant data underlying the results reported in this article can be made available to researchers who provide a methodologically sound proposal, beginning 3 months and ending 5 years following article publication. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.

Additional information

Funding

AM Rapoport serves as an advisor for Allergan, Amgen, Amneal, Biohaven, Cala Health, Impel, Novartis, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc and Zosano; AM Rapoport is also on the speaker bureau of Allergan, Amgen, Biohaven, Lundbeck and Teva Pharmaceutical Industries. M Ameri, H Lewis, DJ Kellerman are employees of Zosano Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing support was provided by P Foreman, and funded by Zosano Pharma.