Satsuma Pharmaceuticals Gains FDA Approval for Atzumi™ Nasal Migraine Treatment

A new chapter in migraine treatment has unfolded with the U.S. Food and Drug Administration (FDA) approving Atzumi, a nasal powder formulation of dihydroergotamine (DHE), specifically for adults experiencing acute migraine attacks, with or without aura. Developed by Satsuma Pharmaceuticals, a biopharmaceutical company focused on innovative treatments for debilitating conditions, Atzumi offers a unique and user-friendly solution to a long-standing medical challenge.

Migraines are notorious for their debilitating effects, interrupting daily life and productivity. The American Migraine Foundation reports that around 40 million people in the United States suffer from migraines, making it a major cause of disability, especially among young women. Atzumi, formerly known as STS101, stands out as the first and only DHE nasal powder on the market, integrating an advanced delivery technology called SMART (Simple MucoAdhesive Release Technology). This platform enhances the convenience of administering DHE, a drug long recognized for its efficacy in treating migraines.

Dr. Ryoichi Nagata, President and CEO of Satsuma Pharmaceuticals, expressed immense satisfaction with the FDA’s approval, highlighting the new potential Atzumi holds for improving patient quality of life. The formulation combines the well-established benefits of DHE with a novel delivery system, offering a reliable treatment option for those enduring the challenges of migraines.

The uniqueness of Atzumi lies in its ability to deliver DHE rapidly and consistently, as demonstrated in clinical trials. With two key studies backing its efficacy and safety, Atzumi showed rapid absorption and sustained DHE concentrations in the bloodstream, providing long-lasting relief from migraine symptoms. The Phase 1 pharmacokinetic trial and the ASCEND Phase 3 open-label trial were pivotal in establishing these outcomes, ensuring the drug's suitability for widespread use.

Dihydroergotamine itself is not new to the therapeutic landscape. Since its introduction in 1946, it has been a cornerstone in migraine treatment guidelines. However, the traditional liquid spray and injectable forms have been criticized for their invasive administration and inconsistent results. Atzumi addresses these drawbacks, offering a more convenient and effective option in the form of nasal powder.

Despite its benefits, Atzumi brings certain safety considerations. A crucial warning accompanies its use, specifically regarding the risk of peripheral ischemia when combined with strong CYP3A4 inhibitors. This combination elevates DHE levels, increasing the chances of vasospasm and potential ischemic events in various parts of the body. As a result, simultaneous use of these inhibitors and Atzumi is contraindicated.

Additionally, Atzumi is not suitable for preventive migraine treatment or for specific migraine types, such as hemiplegic migraine or migraine with brainstem aura. Several contraindications include patients with certain cardiovascular conditions, severe organ impairments, and those taking certain other medications. Patients are also advised of potential adverse reactions, such as rhinitis, nausea, and dizziness, among others.

Satsuma Pharmaceuticals, located in Research Triangle Park, North Carolina, operates as a subsidiary of Shin Nippon Biomedical Laboratories, a renowned contract research organization in Japan. Since its founding in 2016, Satsuma has been on a mission to leverage scientific innovation and advanced technology to address unmet medical needs, especially in the field of drug-device combination products delivered via inhalation.

Atzumi, with its novel approach and validated efficacy, represents a significant advancement in the landscape of migraine treatment, promising to make a meaningful difference in the lives of many patients.