AbbVie drug meets phase 3 goal in menstrual migraine

AbbVie’s atogepant has met the primary endpoint of the phase 3 LUNA trial, which tested the drug as a preventive treatment for menstrual migraine.

Trial results

In the phase 3 LUNA trial, atogepant reduced migraine days during the perimenstrual period by an average of 1.20 days over three menstrual cycles, compared with 0.40 days for placebo – a difference of 0.80 days.

Atogepant is already approved for migraine prevention, but LUNA tested a different approach: taking the drug for seven consecutive days around menstruation to prevent attacks during the period when they are most likely to occur.

There are currently no treatments approved specifically for menstrual migraine.

“Menstrual migraine attacks can be severe, long lasting and disruptive to daily life,” said Primal Kaur, Senior Vice President, Global Development of Immunology, Neuroscience, Eye Care and Specialty, AbbVie.

The term menstrual migraine covers both pure menstrual migraine and menstrually related migraine.

A sizeable patient group

The need for targeted treatment is reflected in the prevalence of menstrual attacks. The CaMEO-I study found that 66% of eligible respondents reported migraine attacks around menstruation.

A survey by the European Migraine and Headache Alliance found that 68% of respondents had never been offered an approach tailored to their menstrual attacks.

“Menstrual migraine attacks are generally more severe and more difficult to treat,” said Cristina Tassorelli, Professor of Neurology and Director, Headache Science Centre, IRCCS Mondino Foundation, University of Pavia.

Targeting the cycle

LUNA was designed around the predictable timing of menstrual migraine attacks. Participants received atogepant or placebo for seven consecutive days, starting three days before menstruation, across three menstrual cycles.

The randomised, double-blind, placebo-controlled phase 3 study enrolled 468 adult women with pure menstrual migraine or menstrually related migraine, with or without aura, across Europe and Asia.

The trial also assessed headache days, acute medication use, functional disability, cognitive function and responder outcomes. Atogepant met all eight ranked secondary endpoints (all p<0.0001). Safety results were consistent with the drug’s known profile, with no new safety signals identified.

Atogepant is an oral CGRP receptor antagonist marketed as AQUIPTA in the EU and QULIPTA in the US, Canada, Israel and Puerto Rico. It is approved in 60 countries.

What comes next for AbbVie?

AbbVie plans to submit the LUNA data to health authorities worldwide and present the findings at future medical congresses.

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