Dihydroergotamine led to significant headache pain reduction at 48 hours, up to 12 months
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Key takeaways:
- Researchers examined 446 individuals with migraine and 9,091 migraine attacks over 12 months.
- Dihydroergotamine, delivered in powder form via nasal spray device, led to rapid and significant headache relief.
SAN DIEGO — Treating migraine with a novel formulation of dihydroergotamine powder was linked to favorable outcomes including significant headache pain reduction at 48 hours post dose that was extended to 12 months.
“(Nasal sprays) have traditionally been difficult to use and they’ve also been plagued with insurance coverage issues,” Shannon Strom, PhD, vice president of regulatory affairs at Satsuma Pharmaceuticals, told Healio at the American Headache Society Annual Scientific Meeting. “So, this medication ends up further down in their treatment armament than it really deserves to be.”
Strom and colleagues aimed to describe long-term effectiveness of STS101 (Satsuma Pharmaceuticals) — a novel, investigational, combination dihydroergotamine mesylate product administered in a nasal powder — over 12 months in the open-label ASCEND clinical trial.
The trial included 446 individuals with a history of at least 1 year of migraine with or without aura, onset before the age of 50 years, four to 12 migraine attacks per month in the 3 months prior to screening and who had intact nasal mucosa at baseline. A total of 9,091 migraine attacks were included for analysis.
Participants were allowed to self-administer the product as needed for up to two doses within 24 hours of a single migraine attack, up to 12 doses per month for 12 months.
From the initial cohort, 172 individuals (mean age 39.1 years; 83.7% female) elected to exclusively utilize the nasal delivery device in the expansion study for a total of 3,394 individual migraine attacks.
The primary efficacy outcomes were the proportion of migraine attacks with headache pain freedom, the proportion free from the most bothersome symptoms and proportion with headache pain relief at 2 hours post-dose.
Results showed significant improvement in all three primary outcomes from 30 minutes to 48 hours post dose: headache pain freedom (4.1% to 88.8%); freedom from most bothersome symptoms (8.3% to 91.5%); headache pain relief throughout (12.3% to 93.5%).
Conversely, from month 1 to month 12, the primary outcomes varied: headache pain freedom (28.5% to 31.3%); freedom from most bothersome symptoms (54.2% to 53.3%); and headache pain relief (66.3% to 57.1%).
The researchers also noted that a second dose of study medication was delivered in 19.3% of migraine attacks within 24 hours and in 19.4% for attacks within 48 hours post-dose.
“What you can see is, within about 3 hours, the proportion of migraine attacks that are suffering from headache pain freedom, freedom from most bothersome symptoms or headache pain relief, those increase proportionally and stay very high,” Strom said.