公开(公告)号：US20220105030A1

公开(公告)日：2022-04-07

申请号：US17492136

申请日：2021-10-01

Applicant: Impel Neuropharma, Inc.

Inventor： John D. Hoekman ,  Kelsey H. Satterly ,  Stephen B. Shrewsbury ,  Scott Youmans ,  Christopher Fuller

IPC: A61K9/00 ,  A61M11/00 ,  A61M11/02 ,  A61M15/00 ,  A61P25/06 ,  A61K31/48 ,  A61K31/522 ,  A61K47/26 ,  A61M15/08

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 AUC0-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.

公开(公告)号：US20210236485A1

公开(公告)日：2021-08-05

申请号：US17148154

申请日：2021-01-13

Applicant: Impel Neuropharma, Inc.

Inventor： John D. Hoekman ,  Kelsey H. Satterly ,  Stephen B. Shrewsbury ,  Scott Youmans ,  Christopher Fuller

IPC: A61K31/4985 ,  A61K9/00 ,  A61K31/522 ,  A61K47/26 ,  A61P25/06

Abstract: Methods are provided for reducing the frequency of migraine attacks in a subject who has frequent migraine headaches with or without aura. The methods comprise intranasally administering to the subject a pharmaceutical composition comprising dihydroergotamine (DHE) or salt thereof on a repeat dose schedule, wherein each intranasal administration is delivered by a manually actuated, propellant-driven, metered-dose administration device, and wherein the schedule is a chronic intermittent schedule in which each of the repeated administrations is performed while the subject is experiencing a migraine headache.

公开(公告)号：US11185497B2

公开(公告)日：2021-11-30

申请号：US17062364

申请日：2020-10-02

Applicant: Impel Neuropharma, Inc.

Inventor： John D. Hoekman ,  Kelsey H. Satterly ,  Stephen B. Shrewsbury ,  Scott Youmans ,  Christopher Fuller

IPC: A61P25/06 ,  A61K9/00 ,  A61M11/00 ,  A61M11/02 ,  A61M15/00 ,  A61K31/48 ,  A61K31/522 ,  A61K47/26 ,  A61M15/08

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 AUC0-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.

公开(公告)号：US20210022995A1

公开(公告)日：2021-01-28

申请号：US17062364

申请日：2020-10-02

Applicant: Impel Neuropharma, Inc.

Inventor： John D. Hoekman ,  Kelsey H. Satterly ,  Stephen B. Shrewsbury ,  Scott Youmans ,  Christopher Fuller

IPC: A61K9/00 ,  A61M15/00 ,  A61P25/06 ,  A61K31/48 ,  A61K31/522 ,  A61K47/26 ,  A61M15/08

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 AUC0-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.

公开(公告)号：US20190209463A1

公开(公告)日：2019-07-11

申请号：US16240639

申请日：2019-01-04

Applicant: Impel Neuropharma, Inc.

Inventor： John D. Hoekman ,  Kelsey H. Satterly ,  Stephen B. Shrewsbury ,  Scott Youmans ,  Christopher Fuller

IPC: A61K9/00 ,  A61K31/48 ,  A61K31/522 ,  A61K47/26 ,  A61M15/08 ,  A61M15/00 ,  A61P25/06

CPC classification number: A61K9/0043 ,  A61K31/48 ,  A61K31/522 ,  A61K47/26 ,  A61M15/002 ,  A61M15/0028 ,  A61M15/0065 ,  A61M15/08 ,  A61P25/06

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 AUC0-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.