In a groundbreaking development for migraine sufferers, Satsuma Pharmaceuticals, Inc., in collaboration with its parent company Shin Nippon Biomedical Laboratories, Ltd. (SNBL), has received approval from the U.S. Food and Drug Administration (FDA) for its new treatment, Atzumi. Designed as a nasal powder, Atzumi is the first and only dihydroergotamine (DHE) nasal powder available for the acute treatment of migraine with or without aura in adults. This innovative treatment is delivered through an easy-to-use and portable device, utilizing the SMART (Simple MucoAdhesive Release Technology) platform to ensure effective delivery of DHE.
Migraine affects approximately 40 million Americans, making it the second leading cause of disability worldwide. The approval of Atzumi marks a significant advancement in providing relief to those who suffer from this debilitating neurological disorder. Satsuma Pharmaceuticals, based in Durham, North Carolina, has been dedicated to developing novel treatments for migraines and other chronic conditions. Dr. Ryoichi Nagata, President and CEO of Satsuma, emphasized the importance of Atzumi’s approval, highlighting its potential to improve the quality of life for patients seeking relief from migraines.
The clinical efficacy of Atzumi was demonstrated through multiple studies, including a Phase 1 pharmacokinetic trial and the ASCEND Phase 3 open-label, long-term safety trial. These studies confirmed fast absorption and sustained DHE plasma levels, showcasing the drug’s effectiveness and safety for individuals with migraines. Dr. Stewart J. Tepper, Vice President of the New England Institute for Neurology and Headache, noted the clinical advantages of DHE in treating migraines, particularly its long-lasting effects and ability to provide relief even when administered late into a migraine attack.
The approval of Atzumi provides a new option for patients, combining the well-known benefits of DHE with a user-friendly delivery system. However, it is crucial for patients and healthcare providers to be aware of the drug’s safety information. Atzumi carries a warning of potential peripheral ischemia when coadministered with strong CYP3A4 inhibitors, as this can elevate serum levels of DHE, increasing the risk of vasospasm and ischemia. Therefore, it is contraindicated in certain conditions, including ischemic heart disease, uncontrolled hypertension, and concurrent use of strong CYP3A4 inhibitors.
Patients should also be informed of potential adverse reactions, which may include rhinitis, nausea, dizziness, and application site reactions, among others. Pregnant women are advised of the risk of preterm labor, and lactating women should avoid breastfeeding during treatment with Atzumi and for three days after the last dose.
Satsuma Pharmaceuticals, a wholly-owned subsidiary of SNBL, has been at the forefront of developing innovative therapeutic products since its founding in 2016. The company specializes in drug-device combination products delivered via inhalation, leveraging cutting-edge technology and proven drug therapies to address unmet medical needs.
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