Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine

Summary

The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine. \* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.

Timeline

Start

2020-06-29

Primary completion

2021-12-09

Completion

2021-12-23

Publications

• Lipton RB, Mosher L, Fountaine RJ. Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study. Pain Ther. 2026 Feb;15(1):325-340. doi: 10.1007/s40122-025-00800-z. Epub 2025 Dec 11.
• Berman G, Mullin K, Smith T, Mosher L, Sweeney S, Fountaine RJ. Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study. Headache. 2025 Jul-Aug;65(7):1180-1189. doi: 10.1111/head.14954. Epub 2025 May 20.
• Mullin K, Croop R, Mosher L, Fullerton T, Madonia J, Lipton RB. Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 Aug;44(8):3331024241259456. doi: 10.1177/03331024241259456.

Drugs

Indications