Objective:

Evaluate efficacy of ubrogepant 100mg PRN for the acute treatment of migraine in participants taking atogepant 60mg QD for the preventive treatment of EM.

Background:

Ubrogepant is approved in the US for acute treatment of migraine in adults, with/without aura.Atogepant is approved in the US and EU for preventive treatment of migraine in adults. 

Design/Methods:

TANDEM,a US, phase 4,two-period,multicenter,open-label safety study,enrolled adults with migraine,with or without aura,and <15 headache days per month across 3 months.In Period 1(P1,Wks1–12),participants were treated with atogepant 60mg QD and their own acute medication,excluding any gepant,for breakthrough migraine attacks.In P2(Wks13–24), participants continued atogepant 60mg QD and used ubrogepant 100mg PRN for breakthrough migraine attacks.In P2,a second ubrogepant dose,or the participants’ own acute medication,was allowed 2–24hrs after the initial ubrogepant dose.Safety was evaluated and treatment-emergent adverse events(TEAEs) were defined as AEs with an onset date ≥date study treatment first dose but <30 days after last dose or Visit 8/Wk24.All efficacy endpoints in this study were exploratory.This analysis evaluated the efficacy of ubrogepant 100mg PRN in P2.During P2 (Wk16,20,24),a structured Investigator Interviewer Questionnaire(IIQ) assessed ubrogepant dosing,pain freedom,and pain relief while the MTOQ-6 assessed treatment optimization. 

Results:

P2 included 211 participants who were treated,had a baseline efficacy assessment,and had ≥1 post-baseline efficacy assessment (mITT population 2).During P2,mean monthly ubrogepant use days over Wks13–24 was 2.13 days (SD,1.86).Monthly and 12-wk mean response rates for pain freedom and relief at 2hrs and sustained pain freedom and relief from 2–24hrs consistently exceeded 50% for breakthrough migraine attacks treated with ubrogepant during P2.Mean MTOQ-6 scores(SD) were 21.7(3.4),22.2(2.9),and 22.4(2.8) during Wks16,20,and 24,respectively.The overall safety results were consistent with the known safety profile of atogepant and ubrogepant.

Conclusions:

Ubrogepant-treated participants recalled high rates of pain freedom and relief,and high treatment optimization when used concomitantly with atogepant 60mg QD.No new safety signals were identified.