Intranasal delivery of dihydroergotamine by precision olfactory device

A technology of dihydroergotamine and dosage, which is applied in the directions of drug delivery, drug devices, and therapeutic nebulizers, etc., can solve problems such as withdrawal

Pending Publication Date: 2020-11-13
IMPEL NEUROPHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the previously approved nasal spray drug-device combination product only provided 32% of the bioavailability of intravenous administration, and the variable potency (among other factors) led to its withdrawal from the market in the EU and other countries, although it is in US still available

Method used

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  • Intranasal delivery of dihydroergotamine by precision olfactory device
  • Intranasal delivery of dihydroergotamine by precision olfactory device
  • Intranasal delivery of dihydroergotamine by precision olfactory device

Examples

Experimental program
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Embodiment 2

[0187] 5.6.2. Example 2: Phase I clinical trial

[0188] A phase I clinical trial was conducted to compare (i) the use of precision nasal delivery in healthy adult subjects Device (Impel NeuroPharma, Seattle) drug-device combination intranasally administered a single divided dose of INP104; (ii) intranasal administration nasal spray (Valeant Pharmaceuticals); and (iii) intravenous D.H.E. (Valeant Pharmaceuticals) Bioavailability of Dihydroergotamine (DHE) Mesylate.

[0189] 5.6.2.1. Study design

[0190] The study was a three-stage, three-way, randomized, open-label, single-dose, crossover, comparative bioavailability study.

[0191] In this study, 36 subjects (approximately equal numbers of males and females) were recruited and randomized. Twenty-eight subjects completed the study. Treatment assignment was randomized in a three-treatment, three-stage balanced crossover study of six sequences as follows, with a 7-day washout period between treatments:

[0192]

[0...

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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 (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 providedare 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 precisionintranasal olfactory delivery device packaged therewith.

Description

[0001] 1. Cross references to related applications [0002] This application claims priority to U.S. Provisional Application No. 62 / 643,657, filed March 15, 2018, and U.S. Provisional Application No. 62 / 613,939, filed January 5, 2018, the disclosures of which are incorporated herein by reference in their entirety. [0003] 2. Background technology [0004] Dihydroergotamine (DHE) is a semi-synthetic derivative of the ergot alkaloid ergotamine, which has been approved for the treatment of migraine for more than 70 years. The exact mechanism of action of DHE is unknown, but it is known that DHE acts as a serotonin receptor agonist, causes vasoconstriction of intracranial blood vessels, and interacts centrally with dopamine and adrenergic receptors. [0005] Oral bioavailability of DHE is poor, and DHE is usually administered subcutaneously, intramuscularly or intravenously as the mesylate salt and, where approved, parenterally by nasal spray. Since migraines are sporadic and oc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/48A61K9/00A61K31/00A61P25/06
CPCA61P25/06A61K31/48A61K9/0043A61M15/08A61M11/08A61M15/009A61M2205/8225A61K31/522A61K9/08A61K47/26A61M11/02A61M15/0063A61M11/002A61M15/002A61M15/0028A61M15/0065
Inventor J·D·赫克曼K·H·萨特利S·B·什雷斯布里S·B·尤曼斯C·富勒
Owner IMPEL NEUROPHARMA INC
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