Nasal Therapy Associated with Pain Relief for Acute Migraine Including in Those with DTT Migraine

New analysis of data from the phase 3 SUMMIT study (NCT04940390) demonstrated that individuals with acute migraine treated with STS101 (dihydroergotamine [DHE] nasal powder; Satsuma Pharmaceuticals, Durham, NC) reported significant improvements in headache pain relief (PR), including those with difficult to treat (DTT) migraine attacks (ie, migraine with allodynia, menstrually-related migraine, and migraine with severe impact), and significant increases in freedom from photophobia, phonophobia, and nausea. These results were presented at the 2024 Annual Scientific Meeting of the American Headache Society (AHS).

The double-blind, randomized, placebo-controlled study included adults with a history of 2-8 moderate or severe migraine attacks and fewer than 15 headache days per month (N=1424; mean age 38.5 years, 79.4% female). Participants self-administered a single 5.2 mg dose of STS101 or placebo to treat one migraine attack of moderate or severe pain intensity. Efficacy results include participants who reported a qualifying migraine attack, received the study medication, and reported efficacy data in at least 1 post-treatment e-Diary. A 4-point scale was used to assess pain from 15 minutes through 48 hours after study treatment. PR was defined as a reduction of moderate or severe headache pain to mild or no headache pain with no prior use of any rescue medication. Nausea, photophobia, and phonophobia symptoms were measured at baseline immediately before treatment of the migraine headache and up to 48 hours after treatment.

• Participants receiving STS101 treatment reported improved headache PR at 2 hours through 48 hours post-dose (range, P=.0001 to P=.005).
• STS101 treatment was associated with a higher response rate for PR (STS101 vs placebo) in those with allodynia (50.2% vs 43.5%), menstrually related migraine attacks (50.0% vs 39.6%), and Headache Impact Test (HIT-6) scores of severe impact (>60) (52.5% vs 42.8%).
• Participants who experienced baseline nausea (n=496), photophobia (n=683), or phonophobia (n=648) had significantly higher responder rates for freedom from these conditions from 3 through 48 hours post-dose when treated with STS101 compared with placebo.