PHASE 3 CLINICAL TRIALS

Study Design

Phase 3 clinical trials

Study Design

PHASE 3 CLINICAL TRIALS

Study design1-3

Two randomized, double-blind, placebo-controlled, multicenter trials, ACHIEVE I and II, evaluated the efficacy and safety of UBRELVY® for the acute treatment of a single migraine attack of moderate or severe intensity in adults with a history of migraine with or without aura, who had 2 to 8 migraine attacks of moderate to severe pain in each of the previous 3 months.

Trial design

Trial design

*While evaluated in the ACHIEVE II trial, the 25 mg dose is not approved for use by the FDA; safety and efficacy have not been established.1,2

  • Patients were randomized to receive an investigational product (IP), either UBRELVY 50 mg (n=886) or UBRELVY 100 mg (n=448), or placebo (n=912)1
  • Patients had 1 to 60 days to treat a moderate to severe migraine with an IP3
  • A second dose of IP or rescue medication (triptan, NSAID, acetaminophen, ergot, or opioid) could be taken from 2 to 48 hours after initial dose of IP2,3

-In the pooled UBRELVY 50 mg group, 37.4% (332/886) took a second dose of IP, while 16.4% (145/886) took rescue medication2,4

-In the UBRELVY 100 mg group, 38.8% (174/448) took a second dose of IP, while 15.2% (68/448) took rescue medication3

Age
Mean (at study entry) 41
Range (years) 18-75

Patient demographics1-3

Age
Mean (at study entry) 41
Range (years) 18-75
Sex
Female 89%
Male 11%
Race
White 82%
Black 15%
Hispanic or Latino 17%

84% of patients did not take rescue medication after the first dose2,3

Long-term safety study

In a 52-week, open-label, Phase 3, multicenter, randomized extension trial, patients who completed 1 of 2 Phase 3 single-migraine attack trials were randomized to receive either usual care, UBRELVY 50 mg, or UBRELVY 100 mg to treat their migraine attacks over the course of the trial.5

IN A 1-YEAR, LONG-TERM STUDY WITH OVER 21,000 MIGRAINE ATTACKS TREATED, PATIENTS DID NOT TAKE THEIR USUAL RESCUE MEDICATION 88% OF THE TIME4,5

404 patients took 15,536 doses of UBRELVY 50 mg, and 409 patients took 16,432 doses of UBRELVY 100 mg5