Allergan expects US FDA to provide a decision on ubrogepant’s NDA next month. Credit: Allergan.

Allergan has reported positive data from the Phase III ACHIEVE II (UBR-MD-02) trial of ubrogepant for the acute treatment of patients with migraine.

Ubrogepant is an oral antagonist of calcitonin gene-related peptide (CGRP) receptor, which is present in the nervous system regions involved in migraine pathophysiology.

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The multi-centre, double-blind, parallel-group ACHIEVE II trial assessed the safety, efficacy and tolerability of 50mg and 25mg doses of the drug. A total of 1,355 adult patients with moderate or severe headache pain intensity participated in the trial.

Co-primary efficacy outcomes were freedom from pain and ‘the most bothersome migraine-related symptom’ at two hours post-initial dose.

Secondary efficacy endpoints included pain relief at two hours and sustained pain relief from two to 24 hours.

Compared to placebo, Allergan’s drug demonstrated significantly greater rates of pain freedom at two hours after treatment with the 50mg or 25mg dose.

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The 50mg dose also led to ‘freedom from the most bothersome disease-related symptom’ at two hours. This dose showed statistical superiority to placebo in the absence of light and sound sensitivities.

Both the doses of ubrogepant were well-tolerated. The adverse event profile of the drug was similar to that of placebo, with the common adverse reaction being nausea.

The company already submitted an application seeking approval from the US Food and Drug Administration (FDA), which is set to provide its decision next month.

If approved, ubrogepant is expected to be the first approved small molecule, oral CGRP receptor antagonist for the acute treatment of migraine.

Allergan central nervous system chief medical officer Mitchell Mathis said: “Ubrogepant is a completely new approach to the acute treatment of migraine. This would expand Allergan’s migraine portfolio that includes Botox, the first FDA-approved, preventive treatment for adults with chronic migraine.

“We are also continuing to advance the Phase III clinical programme for atogepant, our second orally administered gepant specifically for migraine prevention.”