RAPID1 hour to significant migraine pain relief WITH UBRELVY 50 mg1

Secondary endpoint: pain relief at 2 hours with a single dose2,3*

* Pain relief was defined as a reduction in migraine pain from moderate or severe to mild or none post-dose. Rescue medication was the patient's usual acute treatment for migraine.3 Data collected after rescue or second dose was excluded.1  UBRELVY 100 mg was included only in ACHIEVE I.3

84% of patients did not take rescue medication after the first dose 4,5

POWERFULPain freedom with a single dose2,3,6*

Co-primary endpoint: Single-dose pain freedom at 2 hours without rescue medication2,3,6*

  • Pain freedom was defined as reduction from moderate/severe headache pain to no pain.3

* Pain freedom over time was an additional efficacy endpoint. Data collected after rescue or second dose was excluded.6 UBRELVY 100 mg was included only in ACHIEVE I.3

PRIMARY ENDPOINT: 21.2% (95/448) OF PATIENTS WERE COMPLETELY PAIN-FREE AT 2 HOURS (UBRELVY 100 mg)5

PERSISTENTThe only oral gepant with an optional second dose3,7

Substudy: Pain freedom with an optional second dose after 2-hour pain relief8

  • 52% (16/31) of patients who achieved pain reduction at 2 hours with UBRELVY 100 mg became pain-free with a second dose of UBRELVY 100 mg vs 33% (10/30) of patients who received placebo for their second dose8

* Patients who received an initial dose of UBRELVY and requested an optional second dose 2-48 hours after the initial dose were re-randomized either to receive placebo or repeat their previous dose of UBRELVY.3 33% (19/57) of patients who achieved pain reduction with UBRELVY 50 mg at 2 hours became pain-free with placebo as their second dose.8,9

When migraine pain is persistent, UBRELVY gives me a second shot at powerful pain freedom.

—Serena Williams

PROVENSustained pain freedom2*

Secondary endpoint: Sustained pain freedom from 2-24 hours3-5*

  • 21.2% (95/448) of patients were pain-free at 2 hours with UBRELVY 100 mg vs 11.8% (54/456) with placebo (P<0.001)3
  • 15.4% (68/441) of patients sustained pain freedom from 2-24 hours with UBRELVY 100 mg vs 8.6% (39/452) with placebo (P=0.002)3

With UBRELVY 50 mg:

  • 20.5% of patients were pain-free at 2 hours with UBRELVY 50 mg vs 13.05% with placebo3
  • 13.6% of patients who achieved pain freedom with UBRELVY 50 mg at 2 hours remained pain-free at 24 hours vs 8.4% with placebo3

* Sustained pain freedom from 2-24 hours was a secondary efficacy endpoint and was defined as pain freedom with no administration of either rescue medication or second dose of investigational product, and with no occurrence thereafter of mild, moderate, or severe headache during the relevant number of hours after dosing.6 Pain freedom at 48 hours was a secondary (EU only) endpoint.2

72% (62/86) of patients who achieved pain freedom at 2 hours remained pain-free at 48 hours2†

FUNCTIONNormal for most patients at 2 hours2

Additional endpoint: Percentage of patients who achieved normal function over 2-8 hours with a single dose2*

  Patients were asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary).6 *Data collected after rescue or second dose was excluded.3 UBRELVY 100 mg was included only in ACHIEVE I.3

PATIENTS COULD TAKE UBRELVY
RIGHT AWAY OR WITHIN 4 HOURS4

References

1. Goadsby PJ, Blumenfeld AM, Lipton RB, at al. Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications. Cephalalgia. 2021;41(5):546-560. 2. Data on file. Allergan. 3. UBRELVY [package insert]. Madison, NJ: Allergan USA, Inc.; 2021. 4. Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain from the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA. 2019;322(19):1887-1898. 5. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 6. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine [supplementary appendix]. N Engl J Med. 2019;381:2230-2241. doi:10.1056/NEJMoa1813049 7. Allergan receives U.S. FDA approval for UBRELVY™ for the acute treatment of migraine with or without aura in adults. News release. Allergan. Accessed June 15, 2021. 8. Ailani J, Blumenfeld AM, Klein B, et al. An optional second dose of ubrogepant is effective in achieving 2-hour pain freedom in the acute treatment of migraine. Poster presented at: 61st Annual Scientific Meeting of the American Headache Society, July 11-14, 2019; Philadelphia, PA. Poster P112. 9. Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine: phase 3, randomized, 52-week extension trial. Headache. 2020;60(1):141-152.