Fuente: "milk OR dairy products" Headache. 2026 Jan 8. doi: 10.1111/head.70036. Online ahead of print.ABSTRACTOBJECTIVE: This study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10 mg dose of zavegepant nasal spray.BACKGROUND: Zavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene-related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.METHODS: In this Phase 1, open-label, single-arm, single-dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10 mg zavegepant. Blood and breast milk samples were collected over 24 h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single-site in the United States.RESULTS: Geometric mean (geometric percent coefficient of variation [CV%]) milk-to-plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration-time curve from time 0 to 24 h postdose, area under the concentration-time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05 μg/kg/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8 μg/kg/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment-emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.CONCLUSION: A single intranasal dose of 10 mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.PMID:41502343 | DOI:10.1111/head.70036