STS101 DHE Nasal Powder Resolves Photophobia, Phonophobia, and Nausea in Migraine

Dihydroergotamine (DHE) nasal powder — STS101 — demonstrates rapid and sustained resolution of cardinal migraine symptoms, including photophobia, phonophobia, and nausea, according to study findings presented at the 2025 American Headache Society (AHS) Annual Scientific Meeting, held from June 19-22, in Minneapolis, Minnesota, and virtually.

DHE mesylate has been recommended as a first-line treatment for moderate or severe migraine with or without aura. Researchers developed STS101, a US Food and Drug Administration (FDA)-approved drug-device, which uses DHE mesylate powder for nasal administration.

The aim of the study was to determine the effect of STS101 on cardinal symptoms of migraine, using data from the ASCEND trial (ClinicalTrial.gov Identifier: NCT04406649).

Participants from the ASCEND trial eligible for the current analysis had a history of migraine, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), which included migraine before age 50 years; 4 to 12 migraine attacks per month; and less than 15 headache days per month in the 3 months before screening.

Efficacy data were presented for migraines in the intent-to-treat population, defined as participants who received study medication for at least 1 migraine attack.

Cardinal symptoms of migraine, including photophobia, phonophobia, and nausea, were assessed at baseline (before treatment of the migraine with STS101) and up to 48 hours after treatment.

Study endpoint was absence of photophobia, phonophobia, and nausea (if present at baseline) after receiving treatment with STS101.

Of 344 participants (mean age, 40.4 years; women, 85.8%; White, 87.5%) identified for the analysis, 335 used the final device for a total of 6610 migraine attacks. At baseline, participants reported high levels of photophobia (94%), phonophobia (92%), and nausea (60%).

A total of 52.9% of participants with migraine had a resolution of photophobia 2 hours after administration, with 91.6% and 94.1% showing resolution by 24 and 48 hours, respectively.

A total of 58.3% of participants with migraine had a resolution of phonophobia 2 hours after administration, with 93.8% and 94.7% showing resolution by 24 and 48 hours, respectively.

A total of 69.7% of participants with migraine had a resolution of nausea 2 hours after administration, with 94.5% and 93.9% showing resolution by 24 and 48 hours, respectively.

Overall, more than 90% of all migraine attacks were not associated with cardinal symptoms by 24 hours after treatment with STS101.

“The results of the ASCEND study show that, similar to its effects on migraine headache pain and most bothersome headache-associated symptom, STS101 showed rapid and sustained resolution of each of the cardinal migraine symptoms phonophobia, and nausea,” the researchers concluded.

Multiple authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.