‘Exciting potential addition’
Commenting on the findings, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said: “Zavegepant is an exciting potential addition to rimegepant for the acute care of migraine.”
Dr. Alan M. Rapoport
Many patients like the orally dissolving tablet formulation of rimegepant (Nurtec), but some have nausea and do not absorb oral preparations well, said Dr. Rapoport, who is editor-in-chief of Neurology Reviews and a past president of the International Headache Society. “So, it makes sense to have a gepant, which is not a vasoconstrictor and has few adverse events, developed as a nasal spray.” Nasal preparations often work more quickly than oral preparations, he added.
Other intranasal treatments available for migraine include dihydroergotamine (Migranal), zolmitriptan (Zomig), sumatriptan (Imitrex), and ketorolac (Sprix). It is not possible to compare zavegepant with these medications, or with other CGRP receptor antagonists, because they have not been studied in head-to-head trials, said Dr. Rapoport, who was not involved in the study but has previously consulted for Biohaven Pharmaceuticals, the drug’s manufacturer.
“I would predict a nasal spray would work somewhat faster and better in some patients with nausea or poor absorption, so I would be happy to have it approved and available.”
The current study uses endpoints typically prescribed by the U.S. Food and Drug Administration and includes a large sample size, said Dr. Rapoport.
“During the informed consent [stage], the patients in this trial would be told that there is a 3-in-4 chance that they would be getting an active drug versus placebo, and that often increases the placebo response,” he added. “In this trial, a placebo response of 15.5% is slightly high, but not atypical,” he added.
This study raises the question of whether other acute-care migraine medications should be studied as nasal preparations. “I think the answer is yes,” said Dr. Rapoport. “Fast-acting, effective nasal preparations that are easy to use and cause few adverse events [are] what we need.”
Biohaven Pharmaceuticals sponsored the study. Dr. Lipton has been a consultant for Biohaven, has conducted studies funded by the company, and has stock in the company. Dr. Rapoport has consulted and spoken for Biohaven, but did not participate in the current study.
A version of this article first appeared on Medscape.com.