Dihydroergotamine nasal spray for the acute treatment of migraine

Abstract

We conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of dihydroergotamine (DHE) nasal spray and placebo over 4 hours in the treatment of migraine. Of the 112 patients enrolled, 100 were included in the "intent-to-treat" efficacy analysis. The patients self-administered either 2.0 mg DHE (0.5 mg per nostril, repeated after 15 minutes) or placebo at the onset of two separate headaches and rated hourly the drugs' effects on pain severity, pain relief, nausea, and vomiting. The physicians assessed the overall effectiveness of the drugs in relieving headache pain, nausea, and vomiting. Both the patients' and physicians' ratings indicated that DHE was significantly superior to placebo in improving headache and nausea; according to the patients' ratings, these between-group differences were already significant at the first (hour 1) evaluation. There were no significant differential treatment effects with respect to relief of vomiting. Most adverse events were mild or moderate, confined to the nasopharyngeal area, and probably related to the route of administration. We conclude that DHE nasal spray is a safe and effective treatment for the pain and nausea of migraine attacks.

Dihydroergotamine Tartrate Induces Lung Cancer Cell Death through Apoptosis and Mitophagy

“…DHE nasal spray was successful in alleviating migraine-related pain in 47-70% of patients 4 h after treatment [12,13]. Because it is free from side effects and contraindications, aerosol inhalation has a number of advantages for drug delivery.…”

Treatment of Headache Following Triptan Failure After Successful Triptan Therapy

“…Efficacy against placebo in several randomized, controlled trials was statistically achieved as early as 1 h (2 mg) and with pain relief in 70 % at 4 h (3 mg) [13,14].…”

Ergotamine and dihydroergotamine: A review

“…Peak plasma levels occur approximately 1 to 2 minutes after IV administration, 24 minutes after IM administration, and 30 to 60 minutes after IN administration. Intranasal administration of DHE [27] avoids first-pass hepatic metabolism.…”

“…Since that time, ET has consistently proven to be somewhat effective in the treatment of moderate to severe migraine [27][28][29][30]. A variety of dosage forms have been employed to optimize the administration of ET in different clinical situations; because of the variability in bioavailability, the optimal route of administration should be tested before concluding that a patient is not responding to the drug.…”

“…Clinically, DHE has been proven to be highly effective in treating acute migraine with or without aura [37][38][39] and may be administered at any time during the attack, including the aura, in contrast to the triptans. Repetitive IV DHE is a treatment of choice for status migrainous [28] and is particularly effective for the treatment of chronic daily headache (transformed or chronic migraine) and analgesic rebound headache.…”