FDA approves migraine drug formulated for fast dispersion
Zydis is a formulation technology developed by Catalent, that enables the production of freeze-dried tablets that disperse almost instantly in the mouth without water.
Developed by Biohaven and manufactured by Catalent, Nurtec ODT (rimegepant), leverages the Zydis technology in order to offer increased convenience for patients experiencing migraines, the former company stated.
Nurtec, a calcitonin gene-related peptide receptor antagonist, was approved by the US Food and Drug Administration (FDA) as an acute treatment of migraine in adults.
According to Biohaven, the drug is a first-of-its-kind, with a single dose able to provide pain relief within one hour and sustained efficacy that lasts up to 48 hours.
This approval marked the first regulatory approval for a product developed by Biohaven. Following the regulatory approval, Catalent will take over the commercial manufacture of the treatment under an exclusive agreement.
Commenting on the collaborative work, Jonathan Arnold, president of oral and specialty delivery at Catalent, said that Zydis is an ‘ideal’ platform for the delivery of acute migraine treatments.
According to Arnold, “Rapid onset of relief is consistently ranked among the most important attributes of acute migraine medications, along with the benefits of easier administration without water.”
Moreover, at the time of the initiation of the partnership with Catalent, Biohaven’s CEO had stated that quickly dissolving formulations are ‘particularly well suited’ for people with migraines, since such patients “need to take acute treatments promptly, whenever and wherever an attack hits.”
Finally, patients with migraine often have accompanying nausea and have an aversion to consuming food or liquids during an attack.