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Recurrence of acute migraine following ubrogepant and diclofenac buffered solution combination therapy- An observational study

James A Charles* and Nicole Suttora

Objective: To analyze the need for a repeat dose following administration of a single fixed combination dose of ubrogepant and diclofenac potassium buffered solution for an acute migraine attack.

Background: A relapse after pain freedom/relief from a migraine abortive is an acute treatment failure. Reduction of acute disability and prevention of chronification is dependent on effective, rapid, complete abortive treatment without adverse effects.

Methods: Ubrogepant 100 mg tabs and diclofenac potassium buffered solution 50 mg powder (UBR/DICb) are both FDA approved for acute migraine therapy. Twenty-three subjects, 22 female, 1 male with episodic or chronic migraine with and without aura were instructed take both agents within 15 minutes of the migraine attack. Pain freedom and pain relief at 2 hrs were recorded and need for repeat dose for relapse was the primary efficacy outcome measure for this study. Relief of most bothersome symptoms (MBS)-nausea, photophobia, phonophobia, and adverse effects were also recorded. Observation for need for repeat dosing was extended to 24 hrs. Preventives were permitted.

Results: Two hours following a single fixed dose of UBR/DICb, 96% of the enrolled study patients were pain free or obtained pain relief with no need for a second dose, and 4% did not respond. Of the 23 patients enrolled in the study, 87% experienced pain freedom with no need for re-dosing , (CI 95% (0.7, 1.0), and 9% had pain relief with no need for re-dosing (CI 95% (-0.02, 0.2), and 4% had no pain relief or freedom and no response to re-dosing (CI 95% (-0.04, 0.12)). Reduction in MBS paralleled pain reduction in our study cohort. None of the responders required a second dose of UBR/DICb for the next 24 hrs.

Conclusion: At 2 hours, all pain free and pain relief responders to single dose combination ubrogepant and diclofenac buffered solution did not need a repeat dose. Sustained efficacy without re-dosing necessity is maintained for 24 hrs. Single dose combination ubrelvy/ diclofenac buffered solution resulted in a significant reduction in need for a second dose than ubrelvy alone from previously published studies. This small observational study will need to be validated in placebo controlled larger studies.