Comparative bioavailability of single‐dose zavegepant during and between migraine attacks: A phase 1, randomized, open‐label, fixed‐sequence, two‐period study
Zavegepant exposure was comparable during a migraine attack and a non-migraine period, particularly at the therapeutic dose of 10 mg. When averaging over migraine and non-migraine periods, there was a less-than-dose proportional increase in zavegepant exposure when the dose was doubled from 10 to 20 mg. The median T<sub>max</sub> was 0.5 h regardless of migraine attack or dose. Zavegepant 10 and 20 mg exhibited favorable safety profiles during migraine attacks and non-migraine periods, and were effective to relieve pain, associated symptoms, and functional disability during migraine attacks, with no apparent correlation between zavegepant concentration and efficacy outcomes.
Authors
- Jing Liu (ORCID: https://orcid.org/0000-0001-9481-5961)
- Richard Bertz (ORCID: https://orcid.org/0009-0006-4593-1310)
- Julie L. Collins (ORCID: https://orcid.org/0000-0002-3775-2703)
- Lisa Kamen
- Kyle Matschke (ORCID: https://orcid.org/0009-0003-2043-851X)
- Jennifer Madonia (ORCID: https://orcid.org/0009-0000-8060-8478)
- Rajinder Bhardwaj (ORCID: https://orcid.org/0009-0005-2720-2192)
Institutions
- Pfizer (United States) (US)
- Biohaven Pharmaceuticals (United States) (US)
- Certara (United States) (US)
- Integra LifeSciences (United States) (US)
Publication Details
- Journal
- Headache The Journal of Head and Face Pain
- Published
- 2024-11-07
- DOI
- https://doi.org/10.1111/head.14856
- Citations
- 4
- Primary Topic
- Migraine and Headache Studies
- Type
- article
- Field-Weighted Citation Impact
- 1.54
Funders
- Pfizer