Core Viewpoint - Amneal Pharmaceuticals has launched Brekiya®, the first and only ready-to-use dihydroergotamine autoinjector for the acute treatment of migraines and cluster headaches in adults, available exclusively through Walgreens and Sterling Specialty Pharmacy [1][2]. Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, focusing on the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, particularly in the U.S. market [20]. Product Information - Brekiya is indicated for the acute treatment of migraine with or without aura and acute cluster headaches in adults, but it is not intended for the prevention of migraines or treatment of other headache types [5]. - The autoinjector allows patients to self-administer treatment conveniently, potentially reducing emergency room visits [2]. Market Context - Approximately 43 million Americans suffer from migraines, and around 300,000 live with cluster headaches, highlighting a significant market need for effective treatment options [3]. - Headache disorders are the fourth most common reason for emergency department visits in the U.S., accounting for nearly 3% of cases [3]. Pricing and Accessibility - Eligible commercially insured patients may pay as little as $40 per carton, which contains four single-dose autoinjectors, with support from field reimbursement specialists for patient access and coverage questions [8]. Safety Information - Brekiya should not be taken with strong CYP3A4 inhibitors due to the risk of serious interactions that can lead to life-threatening reductions in blood flow [4][6]. - The product is contraindicated for individuals with certain medical conditions, including heart problems, uncontrolled high blood pressure, and peripheral vascular disease [9].

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].