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Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced the publication of data from an open-label, single-center, phase 1 study evaluating the excretion of a single dose of rimegepant 75 mg in the breast milk of healthy lactating women. in the peer-reviewed journal, Breastfeeding medicinethe official journal of the Academy of Breastfeeding Medicine.
This study is particularly important because migraine affects more than 30 million women in America and is the most common cause of disability in women of childbearing age (15-49 years).1,2 Often, for women with migraine, attacks may subside during pregnancy, but resume within 4 weeks of delivery.3 Given the lack of scientific information on migraine medications for nursing mothers, women are often apprehensive about taking their migraine medications while breastfeeding.
The results of the study showed that the excretion of rimegepant in breast milk is very low and that rimegepant was safe and well tolerated by lactating women. It was estimated that, on a weight-adjusted basis, a breastfed infant would receive
Robert Croop, MD, Development Manager – Neurology at Biohaven, commented, “This is important data for women of childbearing age with migraine, as it provides useful new information for those who are breastfeeding and want to breastfeed their babies. Recognizing the lack of available data on migraine medications for breastfeeding women, Biohaven is proud to take a science-based approach by conducting a clinical study in this population.”
The study evaluated 12 healthy breastfeeding women who received a single dose of rimegepant 75 mg with a 36-hour follow-up. The primary objective of this study was to determine whether rimegepant is excreted in breast milk after a single 75 mg dose and to determine the concentration-time profiles of rimegepant in breast milk and plasma of healthy lactating women.
Thomas W. Hale, Ph.D., professor of pediatrics and associate dean for research at Texas Tech University Health Sciences Center School of Medicine, said, “I am very pleased with the results of this clinical trial. Breastfeeding mothers often end up having to choose between taking migraine medication or breastfeeding their babies. Most of the questions we receive at the InfantRisk Center relate to the use of migraine medications while breastfeeding. Now, thanks to this research, we can share with breastfeeding mothers that there is clinical data to support a treatment option while breastfeeding.”
Dr. Hale and Teresa Baker, MD, associate professor and chair of the Department of Obstetrics and Gynecology at Texas Tech University Health Sciences Center School of Medicine, are co-authors of the publication.