Impel Pharmaceuticals Inc.
INTRANASAL DELIVERY OF DIHYDROERGOTAMINE BY PRECISION OLFACTORY DEVICE
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Abstract:
Methods are provided for acutely treating migraine headache with or without aura. The methods comprise administering to a subject with migraine headache an effective dose of a liquid pharmaceutical composition comprising dihydroergotamine (DHE) or a salt thereof, wherein the dose is administered by an intranasal delivery device that provides, following intranasal administration, (a) a mean peak plasma DHE concentration (C.sub.max) of at least 750 pg/ml, (b) with a mean time to C.sub.max (T.sub.max) of DHE of less than 45 minutes, and (c) a mean plasma AUC.sub.0-inf of DHE of at least 2500 pg*hr/ml. Also provided are kits for acutely treating migraine with or without aura in which a liquid pharmaceutical composition comprising DHE or DHE salt is contained within a sealed vial that is attachable to a precision intranasal olfactory delivery device packaged therewith.
Utility
2 Oct 2020
28 Jan 2021