Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study
Year: 2025
Type: article
Abstract: This study aimed to assess changes in patient-reported outcomes during open-label acute treatment of migraine with zavegepant for up to 52 weeks. Data were from a phase 2/3, open-label, long-term safety study of zavegepant for the acute treatment of migraine. Participants with migraine treated migraine attacks of any intensity as needed with one dose of zavegepant 10 mg nasal spray, up to once per day and up to eight times per 28 days, for up to 52 weeks. Pre-specified exploratory endpoints included change in number of migraine days/month, change in Migraine Disability Assessment (MIDAS) Scale, change in Migraine-Specific Quality of Life version 2.1 (MSQ v2.1), and Satisfaction with Medication. A total of 603 treated participants were analyzed. Zavegepant treatment was associated with mean reductions of 1.7 migraine days/month of any pain intensity and 1.1 migraine days/month of moderate or severe pain intensity. Zavegepant treatment was associated with improvement in mean MIDAS total score of − 8.2 (95% CI − 9.89, − 6.55) at week 12 and − 8.8 (95% CI − 11.13, − 6.50) at week 52. At week 12 and week 52, respectively, zavegepant treatment was associated with improvements in mean MSQ Role Function Restrictive domain score of 8.6 (95% CI 7.09, 10.16) and 13.8 (95% CI 11.76, 15.85), improvement in Role Function Preventive domain score of 6.7 (95% CI 5.25, 8.11) and 10.1 (95% CI 8.08, 12.13), and improvement in Emotional Function domain score of 6.8 (95% CI 4.87, 8.72) and 11.3 (95% CI 8.99, 13.70). At week 52, 44.2% (125/283) of participants were completely or very satisfied with zavegepant and 28.6% (81/283) were somewhat satisfied; 124 participants did not complete the Satisfaction with Medication scale at week 52. Through the 52-week study, acute treatment with zavegepant was associated with reduction in mean number of migraine days/month, improvements in migraine-related disability and migraine-specific quality of life, and high levels of patient satisfaction. ClinicalTrials.gov identifier NCT04408794. Migraine is a significant cause of ill health and disability that reduces patients’ quality of life. Zavegepant nasal spray is an acute treatment for migraine that helps stop a migraine attack. The current analyses were from a phase 2/3 open-label study of zavegepant for the acute treatment of migraine for up to 52 weeks. Patient-reported outcome measures assess the burden of illness and the benefits of treatment from the perspective of the patient. Changes in the number of migraine days/month, and changes in migraine-related disability (using the Migraine Disability Assessment Scale) and quality of life (using the Migraine-specific Quality of Life questionairre version 2.1) were assessed along with satisfaction with zavegepant. A total of 603 participants were treated with zavegepant. Zavegepant treatment was associated with mean reductions of 1.7 migraine days/month of any pain intensity and 1.1 migraine days/month of moderate or severe pain intensity. Zavegepant treatment was associated with improvements in migraine-related disability and migraine-specific quality of life at week 12 and week 52. At week 52, 44.2% of participants were completely or very satisfied with zavegepant and 28.6% were somewhat satisfied. In conclusion, this 52-week study found that during treatment with zavegepant 10 mg nasal spray, migraine days per month decreased, migraine-related disability and migraine-specific quality of life improved, and satisfaction was high.
Source: Pain and Therapy
Institutions: Albert Einstein College of Medicine, Pfizer (United States)
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $7,400
Funders: Biohaven Pharmaceuticals, Pfizer
OpenAlex ID: W4417274430