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      Ubrelvy_efficay_banner
      SEE STUDY DESIGN

      Study design3-5

      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 2-8 migraine attacks of moderate to severe pain in each of the previous 3 months. Patients in trials were 89% female, 82% White, 15% Black, 17% Hispanic or Latino, and the mean age at study entry was 41 years (range of 18-75).

      Patients were randomized to receive an IP, either UBRELVY 50 mg (n=887) or UBRELVY 100 mg (n=448), or placebo (n=912). Patients had 1-60 days to treat a moderate to severe migraine with IP. A second dose of IP or rescue medication (triptan, NSAID, acetaminophen, ergot, or opioid) could be taken from 2-48 hours after initial dose of IP.

      IP=investigational product.

      The UBRELVY study included a diverse patient population2:

      38% - triptan responder

      27% - triptan insufficient responder

      35% - triptan naive

      24% - concomitant preventive medication use (topiramate, onabotulinumtoxinA, propranolol, amitriptyline)

      21% - history of depression

      20% - comorbid anxiety

      12% - moderate to severe cardiovascular risk

      In ACHIEVE I and II, 2-24 hours after initial dose of study medication, a percentage of patients in the mITT population took a second dose of study medication (UBRELVY or placebo) or their first choice rescue medication. In the pooled UBRELVY 50 mg study group, 37.4% (n=332/887) took a second dose of IP while 16.4% (145/887) took rescue medication. In the UBRELVY 100 mg group, 38.8% (n=174/448) took a second dose of IP while 15.2% (n=68/448) took rescue medication.2

      Rescue medication used after optional second dose of study medication (UBRELVY or placebo) was UBRELVY 50 mg (n=83/887) 9.4%, UBRELVY 100 mg (n=45/448) 10%.

      mITT=modified intent-to-treat.

      RAPID
      QUICK PAIN RELIEF

      43% OF PATIENTS ACHIEVED PAIN RELIEF AT 1 HOUR—AND MORE THAN 60% OF PATIENTS AT 2 HOURS WITH UBRELVY 50 mg1,2

      With UBRELVY 100 mg:

      40% (173/437) of patients achieved pain relief at 1 hour and 61% (275/448) at 2 hours3

      Secondary endpoint: Pain relief at 2 hours with a single dose1-3*

      ubrelvey-rapid-quick-pain-relief

       

      HELP PATIENTS QUICKLY ACHIEVE MIGRAINE PAIN RELIEF1 

       

      Limitation: The analysis of the additional endpoint at Hour 1 was not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.

      *Pain relief was defined as a reduction in migraine pain from moderate or severe to mild or none postdose.1
       †UBRELVY 100 mg was included only in ACHIEVE I.1

      EFFECTIVE

      ZERO MIGRAINE PAIN, SUSTAINED

      JUST ONE DOSE OF UBRELVY DELIVERED ZERO MIGRAINE PAIN FOR THE MAJORITY OF PATIENTS AT 4 AND 8 HOURS3

      Co-primary endpoint:

      • Single-dose pain freedom at 2 hours without rescue medication1,3,4*
      • At 2 hours, 21% of patients taking UBRELVY 50 mg (182/886) or 100 mg (95/448) were completely pain-free vs 13% (119/912) taking placebo3
      powerful-zero-pain-sustained

      Limitation: The analyses of additional endpoints at Hours 4 and 8 were not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.

      SUSTAINED PAIN FREEDOM

      ZERO MIGRAINE PAIN SUSTAINED FROM 2 TO 24 HOURS—AND IN AN ADDITIONAL ANALYSIS, UP TO 2 DAYS1,3§
      SECONDARY ENDPOINTS: SUSTAINED PAIN FREEDOM FROM 2 TO 24 HOURS||

      UBRLEVY sustained pain freedom

      Limitation: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.

      *Pain freedom was defined as a reduction from moderate/severe headache pain to no pain.1 Pain freedom over time was an additional efficacy endpoint. Data collected after rescue or second dose was excluded.3
      †      UBRELVY 100 mg was included only in ACHIEVE I.1
      §      Pain freedom at 48 hours was a secondary (EU only) endpoint.3
      ||      Sustained pain freedom from 2 to 24 hours 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 pain during the relevant number of hours after dosing.5

      RETURN TO FUNCTION

      Additional endpoint: Percentage of patients achieving normal function* at 2, 4, and 8 hours with a single dose3†

      UBRLVY return to function

       

      UBRELVY HELPED THE MAJORITY OF PATIENTS GET BACK TO NORMAL FUNCTION3

       

      Limitation: The analyses of additional endpoints were not tested in hierarchical order or adjusted for multiplicity. Results could represent chance findings.

      *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).3
      †Data collected after rescue or second dose was excluded.3
      ‡UBRELVY 100 mg was included only in ACHIEVE I.1

      MORE THAN 90,000 PHYSICIANS HAVE PRESCRIBED UBRELVY® OVER 2.5 MILLION TIMES, TREATING OVER 600,000 PATIENTS IN THE UNITED STATES.3  

      As of 08/22

      Every patient is different—UBRELVY studies included a diverse patient population, including those with1,3:

      UBRELVY patient population
      VIEW SAFETY PROFILE

      For more information please contact us, and our team will answer your questions

      Contact Us

      References:

      1. Ubrelvy Israel Prescribing information, July 2022. 
      2. 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. 
      3. Data on file. Allergan. 
      4. Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant, an acute treatment for migraine, improved patient-reported functional disability and satisfaction in 2 single-attack phase 3 randomized trials, ACHIEVE I and II. Headache. 2020;60(4):686-700. 
      5. Supplement to: Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 
      6. Allergan receives U.S. FDA approval for UBRELVY for the acute treatment of migraine with or without aura in adults. Press release. Cision PR Newswire. December 23, 2019. Accessed January 5, 2022. https://www.multivu.com/players/English/8663051-allergan-ubrelvy-acute-treatment-migraine-fda-approval/ 
      7. Serrano D, Lipton RB, Scher Al, et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18:101.

      IL-UBR-220001 | September 2022