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
*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