NASAL ADMINISTRATION

• US 20150144129A1
• Filed: 06/25/2014
• Published: 05/28/2015
• Est. Priority Date: 03/26/2013
• Status: Active Grant

• Current Assignee: OptiNose, Inc.
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: DJUPESLAND, Per Gisle, MAHMOUD, Ramy A., MESSINA, John
• Granted Patent: US 11,554,229 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61M 11/003 by passing the aerosol trough sieves or filters
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0041 with movable piercing or cutting means
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/0045 Means for re-breathing exhaled gases, e.g. for hyperventilation treatment
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate

Abstract

A method of delivering a substance, such as one or more of a triptan, a nasal steroid or carbon dioxide gas, to the nasal cavity of a subject, in particular for the treatment of headaches, for example, migraine, or rhinosinusitis, for example, chronic rhinosinusitis, optionally with polyps, the method comprising the steps of fitting a nosepiece to one nostril of the subject, delivering the substance through the nosepiece to the posterior region of the nasal cavity of the subject.

Claims

1. A method of therapeutically treating a patient, comprising:

administering, in a first step, a therapeutic agent; and

delivering, in a second step, to a location at an interior of a nasal passage of the patient a therapeutic amount of at least one of carbon dioxide or a pH adjusting material, wherein the first step is performed at least one of before, after, before and after, and at the same time as the second step.

2. The method of claim 1, wherein the first step is performed before the second step.

3. The method of claim 1, wherein the first step is performed after the second step.

4. The method of claim 1, wherein the second step is performed at least one of both before and after the first step and at the same time as the first step.

5. The method of claim 1, wherein the location includes an upper posterior region of the nasal passage.

6. The method of claim 1, wherein the therapeutic agent includes a triptan, optionally sumatriptan, optionally in the form of sumatriptan succinate, optionally administered as a powder aerosol.

7. The method of claim 6, wherein the therapeutic agent is delivered in an amount not greater than 30 mg.

8. The method of claim 6, wherein the capsules each contain from 7 to 15 mg of free base of sumatriptan, and optionally each yield an average delivered dose of from 5 to 10 mg.

9. The method of claim 1, wherein the administering comprises delivering a first dose of therapeutic agent from a first capsule into a first nostril, and subsequently delivering a second dose of therapeutic agent from a second capsule into a second nostril.

10. The method of claim 1, wherein the therapeutic agent includes a topical steroid, optionally fluticasone, optionally in the form of fluticasone propionate, optionally administered as a liquid aerosol.

11. The method of claim 10, wherein the therapeutic agent is delivered in amount of at least 75 μ

g daily, at least 100 μ

g daily, at least 200 μ

g daily, at least 400 μ

g daily or at least 800 μ

s daily, optionally delivered in two doses, optionally at least 37.5 μ

g b.i.d., at least 50 μ

g b.i.d., at least 100 μ

g b.i.d., at least 200 μ

g b.i.d. or at least 400 μ

g b.i.d.

12. The method of claim 10, wherein the delivering comprises:

placing a mouthpiece into a mouth of the patient and a nosepiece into a nostril of the patient, the mouthpiece being fluidly connected to the nosepiece; and

the patient exhaling a breath into the mouthpiece to create a fluid flow out of the nosepiece;

wherein the therapeutic agent when intranasally administered has a systemic bioavailability or pharmacokinetic (PK) profile which is equivalent to or not greater than the systemic bioavailability of 50 ug of the therapeutic agent when intranasally administered without the delivering.

13. The method of claim 1, wherein the second step adjusts a pH in the nasal passage location by an amount ranging from about 0.01 to about 0.5 pH units.

14. The method of claim 13, wherein the amount ranges from about 0.1 to about 0.2 pH units.

15. The method of claim 1, wherein the second step comprises delivering a concentration of carbon dioxide from about 1% vol/vol to about 10% vol/vol carbon dioxide.

16. The method of claim 15, wherein the concentration of carbon dioxide is from about 5% to about 6% vol/vol carbon dioxide.

17. The method of claim 1, wherein delivering comprises:

placing a mouthpiece into a mouth of the patient and a nosepiece into a nostril of the patient;

the patient exhaling a breath into the mouthpiece to create a fluid flow out of the nosepiece; and

directing the fluid flow to the location within the nasal passage.

18. The method of claim 17, wherein delivering further comprises:

adjusting a pH at the location by controlling the fluid flow.

19. The method of claim 18, wherein controlling the fluid flow includes at least one of controlling a duration, a rate, a pressure, and a composition of the fluid flow.

20. The method of claim 19, comprising controlling the fluid flow duration to be in a range of from about 2 to about 3 s.

21. The method of claim 20, comprising controlling the fluid flow rate at least 10 L/min, optionally at least 20 L/min, and optionally at about 30 L/min.

22. The method of claim 17, wherein the delivering further comprises:

placing the nosepiece into a second nostril of the patient;

the patient exhaling a breath into the mouthpiece to create a second fluid flow out of the nosepiece; and

directing the second fluid flow to a second location within a second nasal passage.

23-80. -80. (canceled)