EFFICACY, SAFETY, AND TOLERABILITY OF DIHYDROERGOTAMINE NASAL SPRAY AS MONOTHERAPY IN THE TREATMENT OF ACUTE MIGRAINE

Recently, a new nasal spray formulation of dihydroergotamine was devel oped which facilitates at-home treatment of migraine. we studied the e fficacy. safety, and tolerability of dihydroergotamine nasal spray as monotherapy in the acute treatment of classic and common migraine in t wo, identical, double-blind, randomized, placebo-controlled trials. Of the 229 patients enrolled, 206 (102 dihydroergotamine nasal spray, 10 4 placebo) were included in the intent-to-treat analyses; 182 treated two headaches and 24 treated one headache. Based on both the patients' and physicians' ratings, dihydroergotamine nasal spray was significan tly superior to placebo for reducing the severity of headache pain in both studies, and in relieving nausea in Study 2. The onset of signifi cant efficacy with dihydroergotamine nasal spray compared to that with placebo for both severity of headache pain and relief of nausea occur red at 1 hour in Study 2 and at 3 hours in Study 1. Dihydroergotamine nasal spray was also significantly superior to placebo for the relief of headache pain in both studies. Based on the physicians' global eval uations of treatment efficacy for headache pain. 71% of the dihydroerg otamine-treated patients in Study 2 and 59% of their counterparts in S tudy 1 were considered to be responders. The dihydroergotamine-treated patients had lass newly-occurring vomiting than the placebo-treated p atients. The majority of adverse events reported by the dihydroergotam ine-treated patients were nasopharyngeal. The results demonstrate the efficacy, safety, and tolerability of dihydroergotamine nasal spray as monotherapy in the treatment of acute migraine attacks.