Intranasal delivery of dihydroergotamine by precise olfactory organ device

摘要

Methods for acute treatment of migraines with or without signs are provided. The methods include administering to a subject with a migraine headache an effective dosage of a liquid pharmaceutical composition comprising dihydroergotamine (DHE) or a salt thereof, wherein the dosage is after intranasal administration (a) at least 750 pg. Provides an average peak plasma DHE concentration (C _max ) of /ml, (b) the average time to reach C _max of DHE (T _max ) is less than 45 minutes, and (c) at least 2500 pg*hr/ml of DHE Is administered by an intranasal delivery device that provides an average plasma AUC of _0-inf . In addition, kits are provided for acute treatment of migraines with or without symptoms, wherein a liquid pharmaceutical composition comprising DHE or DHE salt is contained in a sealed vial that can be attached to a precision intranasal olfactory delivery device packaged together. do.