Lundbeck demonstrates leadership and unwavering commitment to advancing migraine management and supporting patient outcomes with six presentations at the 2025 International Headache Congress (IHC), including three oral presentations on eptinezumab (Vypeti®) and Lu AG09222 (anti-PACAP mAb)New data from the open-label extension of the RESOLUTION trial and the primary results of the SUNSET extension trial will be presented for the first time at IHC1,2Patients treated with eptinezumab experienced sustained red ...

Core Insights - Axsome Therapeutics, Inc. is presenting data from the SYMBRAVO clinical program at the 67th Annual Scientific Meeting of the American Headache Society, highlighting its advancements in treating central nervous system disorders [1] Group 1: SYMBRAVO Clinical Data - The SYMBRAVO program includes multiple presentations, such as the efficacy of SYMBRAVO based on migraine-associated disability from the INTERCEPT trial [1] - Long-term effects of SYMBRAVO on headache burden and quality of life will be discussed, showcasing results from the MOVEMENT trial [1] - Topline results from the EMERGE trial will focus on the efficacy and safety of SYMBRAVO in patients with inadequate response to oral CGRP inhibitors [1] Group 2: Product Information - SYMBRAVO is a novel oral medication combining meloxicam and rizatriptan, approved for acute migraine treatment in adults [2] - The formulation utilizes MoSEIC technology for rapid absorption and prolonged plasma half-life, aiming for effective migraine pain relief [2] - SYMBRAVO is not intended for migraine prevention or treatment of specific types of migraines such as hemiplegic or basilar migraines [4] Group 3: Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system conditions, with a portfolio that includes FDA-approved therapies for major depressive disorder and narcolepsy [30] - The company aims to address significant gaps in care through differentiated products and novel mechanisms of action [30] - Axsome's mission is to improve patient outcomes for neurological and psychiatric conditions affecting over 150 million people in the U.S. [30]

Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a mission to address significant gaps in care and improve patient outcomes through innovative products [3] - The company has an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3] Industry Context - Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide, highlighting the critical need for effective treatment options [2] - The Association of Migraine Disorders emphasizes the importance of funding and advancing migraine research, as well as educating patients and healthcare providers about the condition [2] Community Engagement - In recognition of Migraine and Headache Awareness Month, Axsome is supporting various Miles for Migraine Run, Walk or Relax events across the U.S. and providing resources for patients and their families affected by migraine [1][3] - The company collaborates with leading migraine advocacy organizations to share educational resources and support for individuals impacted by migraine [3][5]

Core Insights - Axsome Therapeutics has launched SYMBRAVO, a novel treatment for acute migraine, which combines meloxicam and rizatriptan, targeting multiple pathways involved in migraine attacks [1][4][30] - SYMBRAVO provides rapid pain relief within 2 hours and can sustain pain freedom for up to 24 hours in some patients after a single dose [1][4] - The treatment addresses a significant unmet need, as 63% of migraine patients reported dissatisfaction with their current treatment options [2][30] Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [30] - The company utilizes its patented MoSEIC™ technology to enhance the absorption and effectiveness of its migraine treatment [4][30] - Axsome is committed to improving patient outcomes through comprehensive support services, including the SYMBRAVO On My Side program, which offers financial assistance and educational resources [3][30] Industry Context - Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide [2][30] - The introduction of SYMBRAVO is expected to provide a valuable new option for patients who have not found relief with existing treatments [2][30] - The National Headache Foundation emphasizes the importance of new FDA-approved options to address the needs of the migraine community [2]

Core Viewpoint - Amneal Pharmaceuticals has received FDA approval for Brekiya, the first and only dihydroergotamine autoinjector for the acute treatment of migraines and cluster headaches in adults [1][4]. Product Overview - Brekiya autoinjector offers sustained pain relief in a self-administered format, containing the same medication used in hospitals [2][3]. - The device is easy to use, requiring no refrigeration or assembly, and allows for subcutaneous injection into the thigh [2][3]. - It is designed for patients who may not respond well to oral medications or have conditions that delay treatment [2][4]. Market Context - Approximately 39 million Americans suffer from migraines, with around one million experiencing cluster headaches [4]. - Headaches are a leading cause of emergency room visits, accounting for 3% of all visits in the U.S. [4]. - Brekiya addresses a significant gap in treatment options for cluster headaches, which are often underserved [4]. Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company focused on developing a diverse portfolio of over 280 pharmaceuticals, including injectables and biosimilars [22]. - The company aims to expand its presence in complex product categories and therapeutic areas, particularly in central nervous system and endocrine disorders [22].