An intranasal formulation of dihydroergotamine mesylate (DHE) has been granted approval by the US Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adult patients.

The phase 3 STOP 301 trial had shown that intranasal DHE was safe and well tolerated over a 52-week duration for the acute treatment of migraine. The most commonly reported adverse events related to the nasal spray included nasal congestion and discomfort, nausea, abnormal olfactory test results, and vomiting. Exploratory outcomes for efficacy revealed that 38% of patients had freedom from pain, 2 hours following a single dose. About 7.1% of these had migraine recurrence at 24 hours, while 14.3% had migraine recurrence at 48 hours. Nearly 52% of patients reported that they were free from their most bothersome symptom at 2 hours after treatment. Around 66.3% of the patients reported pain relief at 2 hours following their first attack treated with the intranasal formulation… (Medscape)