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On May 1, 2025, we reported on the US FDA approval of STS 101 (dihydroergotamine [DHE]) nasal powder for the acute treatment of migraine with or without aura in adults.
The approval
STS101, to be marketed as Atzumi (Satsuma Pharmaceuticals), is the first DHE nasal powder product to receive approval from the FDA. The drug device product combines Satsuma's proprietary advanced DHE powder formulation with a novel nasal delivery device that was designed to simplify administration and improve portability.
The FDA approval of the 505(b)(2) New Drug Application for STS101 was based on data from 2 clinical studies, a phase 1 pharmacokinetics (PK) trial and the ASCEND phase 3 open-label, long-term safety trial.
In the ASCEND trial, DHE powder (6.2 mg DHE mesylate) STS101, delivered via a prefilled, single-use nasal device was evaluated over 18 months. The 344 participants had a mean age of 40 years and reported migraine with or without aura expressed as 4 to 12 monthly migraine attacks, and fewer than 15 headache days per month in the 3 months preceding screening. Participants self-administered DHE powder as needed for migraine attacks, with a maximum of 2 doses within 24 hours and up to 12 doses per month.
Among the 47.4% reported migraine with aura and 31.7% reported allodynia. Across a reported 6610 migraine attacks, approximately 19.9% required a second dose. The most common treatment-emergent adverse events (TEAEs) were nasal discomfort (11.3%), dysgeusia (7.6%), nasal congestion (5.2%), nasopharyngitis (5.2%), and nausea (4.9%), with the majority being mild or moderate. Severe TEAEs occurred in only 2.6% of participants. A total of 25.9% of participants experienced a TEAE considered related to study treatment, and the rate of severe TEAEs was 0.2% per treated attack.
The safety profile of STS101 was comparable to that of the previously available dihydroergotamine 1.45 mg liquid nasal spray, which had reported rhinitis (26%), nausea (10%), vomiting (4%), dysgeusia (8%), application site reaction (6%), and dizziness (4%) as common adverse events. No new safety signals related to the novel powder formulation or delivery route were identified.
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