Nurtec ODT was evaluated in a phase 4, randomized, double-blind, placebo-controlled study (N=652) to assess the efficacy and tolerability for the preventive treatment of migraine in adults with a history of inadequate response to traditional OPM use.^1∥

Limitations: This study evaluated the efficacy of rimegepant 75 mg vs placebo for the preventive treatment of migraine in adults with a history of inadequate response to traditional oral preventive medications. The results do not imply that rimegepant is superior to other migraine preventive therapies. The clinical implications of these findings may vary, as there are no universally accepted criteria for defining “inadequate response” to oral preventive medications for migraine.

Most traditional standard-of-care oral preventive medications were not specifically designed for the prevention of migraine and are used based on clinical judgment and guideline recommendations.¹

Primary endpoint^1,4

• Mean change from the observation phase in MMDs across the 12-week double-blind 
treatment phase

Key secondary endpoints^1,4#

• Participants with ≥50% reduction from the observation phase in MMDs with moderate or severe pain across the 12-week double-blind treatment phase
• Mean change from the observation phase in MMDs across weeks 1–4 of the double-blind treatment phase
• Mean change from the observation phase in MMDs across weeks 9–12 of the double-blind treatment phase

Additional secondary endpoints^1,4#

• Mean change from baseline in MIBS score at week 12 of the double-blind treatment phase
• Mean change from baseline in MSQoL restrictive role function score at week 12 of the double-blind treatment phase

Select inclusion criteria⁴

• Participants 18–65 years of age
• ≥1-year documented history of migraine with or without aura according to ICHD-3
  • Migraine onset before age 50 years
  • Migraine attacks lasting approximately 4–72 hours, if untreated
  • 4–14 migraine days, on average, across the 3 months prior to the screening visit and during the 28-day OP**
  • <15 days with headache (including <7 nonmigraine) per month in the 3 months prior to the screening visit or during the 28-day OP
• Prior inadequate response, within 10 years of the screening visit, to agents across 2–4 categories of OPMs^††
  • Category 1: valproic acid
  • Category 2: other anticonvulsant (specifically gabapentin or topiramate)
  • Category 3: beta blocker
  • Category 4: tricyclic antidepressant (specifically amitriptyline)
  • Category 5: SNRI (specifically desvenlafaxine or venlafaxine)
  • Category 6: calcium channel blocker (specifically flunarizine or verapamil)
  • Category 7: angiotensin blocker (specifically candesartan or lisinopril)
  • Category 8: any other locally approved or otherwise recognized oral preventive medication

Select exclusion criteria^1,4

• History of cluster headache, migraine with brainstem aura, or hemiplegic migraine
• Current medication overuse headaches
• Current evidence of uncontrolled, unstable, or recently diagnosed (within 6 months prior to the screening visit) cardiovascular disease^‡‡
• Inadequate response to agents across >4 categories of OPM medications^§§
• Use of preventive medications within the 30 days prior to screening (12 weeks for botulinum injection and 24 weeks for injectable monoclonal CGRP antibodies) and through the study were not permitted
• Non-narcotic analgesic use for >14 days per month and narcotic use for >3 days per month during the 3 months prior to screening

Eligible subjects must have experienced, within 10 years of the screening visit, inadequate response to specified agents across 2–4 of the categories of OPMs where at least 1 example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication). Individuals with a history of inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to medications across >4 of the categories were excluded.⁴

Lack of efficacy^4¶¶
When prior treatment with an OPM has yielded no meaningful reduction in headache frequency (eg, <50% reduction in frequency and/or severity of monthly migraine days) after administration of the respective medication for an adequate period of time (at least 2–3 months) at generally accepted therapeutic dose(s) based on the investigator’s assessment.

Prior intolerance^4¶¶
When prior treatment with an OPM has been previously interrupted because of adverse event(s) that made continuation of the drug unacceptable, as determined by the principal investigator and documented within the medical record.

Contraindication^4¶¶
When an OPM is contraindicated or otherwise considered inadvisable in accordance with locally recognized labeling, practice guidelines, and/or the current standard of care, as determined by the principal investigator with rationale documented within the medical record.

Prior inadequate response: Lack of efficacy, prior intolerance, or contraindication within 10 years of the screening visit¹

Number of oral preventive medication (OPM) categories with prior inadequate response¹