Pfizer has submitted a new drug application (NDA) with China's National Medical Products Administration (NMPA) for zavegepant nasal spray, intended for the acute treatment of migraine with or without aura. The treatment is a CGRP receptor antagonist, which received US regulatory approval in 2023 as the first CGRP receptor antagonist nasal spray for this indication. The submission follows positive Phase II/III and Phase III trial results demonstrating that zavegepant provided significantly greater pain relief at 2 and 3 hours post-dose compared to placebo. This marks Pfizer's second CGRP-targeting migraine therapy to seek approval in China, following the approval of the orally disintegrating tablet rimegepant in 2024.

Migraine is a chronic neurovascular disorder affecting an estimated 1.3 billion people globally, characterised by recurrent, severe headache attacks. Current treatment options can be limited, creating a significant unmet need. Pfizer's application for zavegepant introduces a new, non-oral administration route that may offer an alternative for patients who experience nausea or vomiting during attacks.

PharmCube's NextBiopharm® database shows that, although zavegepant features a new administration method, it is the fourth CGRP receptor inhibitor to enter the global market. Click here to request a free trial for NextBiopharm®.