INTRANASAL DELIVERY OF DIHYDROERGOTAMINE BY PRECISION OLFACTORY DEVICE

Compositions are provided for use in methods of 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 d...

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Bibliographische Detailangaben
Hauptverfasser: SATTERLY, Kelsey, H, SHREWSBURY, Stephen, B, FULLER, Christopher, HOEKMAN, John, D, YOUMANS, Scott, B
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:Compositions are provided for use in methods of 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 (Cmax) of at least 750 pg/ml, (b) with a mean time to Cmax (Tmax) of DHE of less than 45 minutes, and (c) a mean plasma AUCo-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.