NEW HAVEN — Having already gotten one migraine drug approved by the federal Food and Drug Administration and another nearing review by the regulatory agency, Biohaven Pharmaceuticals is advancing a third treatment to deal with the problem.
FDA officials have authorized the initiation of Phase I clinical trials of the drug candidate Zavegepant in an oral formulation. The human testing will assess the safety of Zavegepant and how it interacts with the body.
The FDA testing authorization comes as Phase III trials of the nasal spray Vazegepant are nearing conclusion. The drug is designed to prevent migraines.
Dr. Vlad Coric, Biohaven’s chief executive officer, said Vazegepant will be submitted to the FDA for approval sometime before the end of this year with the possibility of regulatory approval sometime early next year.
Biohaven already has one migraine drug with FDA approval. The FDA approved the sale of Nurtec ODT in late February for the treatment of migraines.
Nurtec comes in rapidly dissolving tablet form.
Coric said that while the current focus is on migraines, the drug delivery system that Zavegepant, Vazegepant and Nurtec use someday can be applied to the treatment of other health problems.
“It's about the platforms: By having different compounds, we are thinking of other disorders besides migraines,” he said. “You should think of this as going after non-migraine indications including COPD, asthma, psoriasis and post-traumatic headaches that follow concussions.”
Biohaven’s stock trades on the New York Stock Exchange under the ticker symbol BHVN. The stock was at $62.85 when trading closed on Thursday.