Key Developments

In March 2023, Pfizer Inc., American multinational pharmaceutical and biotechnology corporation has announced FDA approval of ZAVZPRET (zavegepant), the first CGRP receptor antagonist nasal spray for treating migraines in adults, with or without aura. In its Phase 3 study, ZAVZPRET showed superiority over placebo in achieving pain freedom and relief from bothersome symptoms two hours post-dose. The study also revealed pain relief as early as 15 minutes after administration compared to placebo.
In June 2021, Amneal Pharmaceuticals, Inc. Pharmaceuticals company has announced that the FDA accepted its 505(b)(2) New Drug Application for a dihydroergotamine (DHE) prefilled syringe autoinjector. They expect a decision by mid-2022, with a potential commercial launch in the second half of the same year, focusing solely on the U.S. market. Joseph Todisco, Amneal Specialty's Chief Commercial Officer, emphasized their commitment to expanding the Specialty portfolio by providing impactful therapies for patients in need, particularly in the migraine and headache space.
In June 2021, AstraZeneca biopharmaceutical company declared an agreement with Grünenthal, acquiring global rights to Zomig (zolmitriptan) outside of Japan. Zomig is utilized for the acute management of migraines and cluster headaches, a therapeutic area not within AstraZeneca's primary strategic focus.
In May 2021, Unity HA , medical device company disclosed that the U.S. Food and Drug Administration (FDA) had awarded Breakthrough Device Designation to the Pulsante SPG Microstimulator System for addressing acute pain linked with chronic cluster headaches.