Intranasal administration

Patent metadata

Field	Value
Publication number	US-2021322690-A1
Application number	US-202117338962-A
Country	US
Kind code	A1
Filing date	Jun 4, 2021
Priority date	Nov 19, 2014
Publication date	Oct 21, 2021
Grant date	—

Abstract

A delivery device for and method of modulating a condition relating to social cognition and/or behaviour in a human subject using oxytocin, non-peptide agonists thereof and/or antagonists thereof, comprising: providing a nosepiece to a first nasal cavity of the subject; and providing a supply unit for administering less than 24 IU of oxytocin, non-peptide agonists thereof and/or antagonists thereof through the nosepiece to an upper region posterior of the nasal valve which is innervated by the trigeminal nerve.

First claim

1 - 71 . (canceled)

72 . A delivery device for modulating a condition in a human subject, comprising:
a mouthpiece configured to fit within an oral cavity of the subject and permit the subject to exhale therethrough, whereby exhalation by the subject causes closure of an oropharyngeal velum of the subject; a nosepiece fluidly connected to the mouthpiece and configured to fit within a nostril of the subject, wherein the device is configured to deliver an exhalation breath of the subject from the mouthpiece, through the nosepiece and into a nasal cavity of the subject; and a delivery pump manually actuatable, on each actuation, to deliver a metered dose of a peptide through the nosepiece to an upper posterior region of the nasal cavity, posterior of a nasal valve of the subject, innervated by the trigeminal nerve, each metered dose containing less than 24 IU.

73 . The delivery device of claim 72 , wherein the peptide comprises Orexin-A.

74 . The delivery device of claim 73 , wherein the peptide is for the treatment of narcolepsy.

75 . The delivery device of claim 72 , wherein the peptide comprises insulin.

76 . The delivery device of claim 75 , wherein the peptide is for the treatment of diabetes.

77 . The delivery device of claim 72 , wherein the peptide is delivered as a liquid spray.

78 . The delivery device of claim 72 , wherein each dose contains less than 15 IU.

79 . The delivery device of claim 72 , wherein each dose contains greater than 1 IU.

80 . The delivery device of claim 72 , wherein the nasal valve is expanded by fitting of the nosepiece to have a cross-sectional area which is at least 1.5 times an unexpanded cross-sectional area of the nasal valve.

81 . The delivery device of claim 72 , wherein the nosepiece includes a tip which extends into and expands the nasal valve.

82 . The delivery device of claim 72 , wherein the nosepiece comprises a base portion defining a flow passage therethrough, and a projection at a distal end of the base portion providing a tip configured to extend into and expand the nasal valve, the projection having a rigidity in a sagittal direction and a flexibility in a lateral direction, orthogonal to a sagittal plane.

83 . A method of modulating a condition in a human subject, comprising:
fitting a mouthpiece to an oral cavity of the subject; fitting a nosepiece fluidly connected to the mouthpiece to a nostril of the subject; the subject exhaling through the mouthpiece to deliver an exhalation breath from the mouthpiece, through the nosepiece and into a nasal cavity of the subject; and manually actuating a delivery pump, on each actuation, to deliver a metered dose of a peptide through the nosepiece to an upper posterior region of the nasal cavity, posterior of a nasal valve of the subject, innervated by the trigeminal nerve, each metered dose containing less than 24 IU.

84 . The method of claim 83 , wherein the peptide comprises Orexin-A.

85 . The method of claim 84 , wherein the peptide is for the treatment of narcolepsy.

86 . The method of claim 83 , wherein the peptide comprises insulin.

87 . The method of claim 86 , wherein the peptide is for the treatment of diabetes.

88 . The method of claim 83 , wherein the peptide is delivered as a liquid spray.

89 . The method of claim 83 , wherein each dose contains less than 15 IU.

90 . The method of claim 83 , wherein each dose contains greater than 1 IU.

91 . The method of claim 83 , wherein the nasal valve is expanded by fitting of the nosepiece to have a cross-sectional area which is at least 1.5 times an unexpanded cross-sectional area of the nasal valve.

92 . The method of claim 83 , wherein the nosepiece includes a tip which extends into and expands the nasal valve.

93 . The method of claim 83 , wherein the nosepiece comprises a base portion defining a flow passage therethrough, and a projection at a distal end of the base portion providing a tip configured to extend into and expand the nasal valve, the projection having a rigidity in a sagittal direction and a flexibility in a lateral direction, orthogonal to a sagittal plane.

94 . The method of claim 83 , wherein delivery of the metered dose of the peptide provides for less than a 20% change in a plasma concentration of vasopressin in the subject.

Assignees

• Optinose As

Inventors

• Djupesland Per Gisle
• Mahmoud Ramy A
• Andreassen Ole A
• Westlye Lars T
• Quintana Daniel S
• Smerud Knut T
• Sheldrake Colin David

Classifications

• A61K38/095

  Oxytocins; Vasopressins; Related peptides · CPC title

• A61K9/0043

  Nose · CPC title

• A61M11/00 Primary

  Sprayers or atomisers specially adapted for therapeutic purposes (in general B05B; {aerosol containers B65D83/14}) · CPC title

• A61K38/22 Primary

  Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35) · CPC title

• A61M15/009

  using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08) · CPC title