NASAL ADMINISTRATION

• US 20150053201A1
• Filed: 03/26/2014
• Published: 02/26/2015
• Est. Priority Date: 03/26/2013
• Status: Abandoned Application

• Current Assignee: OptiNose AS (OptiNose, Inc.)
• Original Assignee: OptiNose AS (OptiNose, Inc.)
• Inventors: DJUPESLAND, Per Gisle, MAHMOUD, Ramy A., MESSINA, John
• Application Number:
  US14/226,287
• Publication Number:
  US 20150053201A1
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/006 operated by applying mechanical pressure to the liquid to be sprayed or atomised
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• 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 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/105 Filters A61M16/047, A61M16/22 take precedence; water traps A61M16/08
• CPC Class Codes: A61M 16/1075 by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/12 by mixing different gases
• 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 2202/0225 Carbon oxides, e.g. Carbon dioxide
• 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 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/06 : Antimigraine agents

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 sumatriptan, optionally in the form of sumatriptan succinate, optionally administered as a powder aerosol.

7. 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.

8. The method of claim 7, wherein the therapeutic agent is delivered in amount of at least 100 ug, optionally twice daily.

9. The method of claim 8, wherein the therapeutic agent is delivered in amount of at least 200 ug, optionally twice daily.

10. The method of claim 9, wherein the therapeutic agent is delivered in amount of at least 400 ug, optionally twice daily.

11. The method of claim 8, 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;

and 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.

12. 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.

13. The method of claim 12, wherein the amount ranges from about 0.1 to about 0.2 pH units.

14. 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.

15. The method of claim 14, wherein the concentration of carbon dioxide is from about 5% to about 6% vol/vol carbon dioxide.

16. 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.

17. The method of claim 16, wherein delivering further comprises:

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

18. The method of claim 17, wherein controlling the fluid flow includes at least one of controlling a duration, a rate, a pressure, and a composition of the fluid flow.

19. The method of claim 18, comprising controlling the fluid flow duration to be in a range of from about 2 to about 3 seconds.

20. The method of claim 19, comprising controlling the fluid flow rate at at least 10 L/min, optionally at least 20 L/min, and optionally at about 30 L/min.

21. The method of claim 16, 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.

22. A method for increasing a therapeutic effect of a pharmaceutical agent delivered to a patient, comprising:

delivering a fluid flow to a nasal passage of the patient to deliver about 5% to about 6% vol/vol carbon dioxide to a posterior region of the nasal passage; and

administering a dose of the pharmaceutical agent to the patient.

23. The method of claim 22, further including lowering a pH of the posterior region of the nasal passage.

24. The method of claim 22, wherein the pharmaceutical agent includes sumatriptan, optionally in the form of sumatriptan succinate, optionally administered as a powder aerosol.

25. The method of claim 22, wherein the pharmaceutical agent includes a topical steroid, optionally fluticasone, optionally in the form of fluticasone propionate, optionally administered as a liquid aerosol.

26. The method of claim 25, wherein the pharmaceutical agent is delivered in amount of at least 100 ug, optionally twice daily.

27. The method of claim 26, wherein the pharmaceutical agent is delivered in amount of at least 200 ug, optionally twice daily.

28. The method of claim 27, wherein the pharmaceutical agent is delivered in amount of at least 400 ug, optionally twice daily.

29. The method of claim 26, 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;

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

30. A method of treating a patient, comprising delivering a concentration of about 5% to about 6% vol/vol carbon dioxide to a nostril of the patient to lower a pH of an upper posterior region of the nasal passage by at least about 0.1 pH units to provide a therapeutic or pharmacokinetic effect.

31. The method of claim 30, further including administering a therapeutic agent to the patient at least one of orally, intranasally, intravenously, and sub-cutaneously.

32. The method of claim 30, further including administering a dose of sumatriptan powder intranasally.

33. The method of claim 32, the low dose includes less than 20 mg of a sumatriptan powder, optionally about 16 mg of sumatriptan powder, optionally in the form of sumatriptan succinate.

34. The method of claim 30, further including administering a topical steroid, optionally fluticasone, optionally in the form of fluticasone propionate, optionally administered as a liquid aerosol.

35. The method of claim 34, wherein the steroid is delivered in amount of at least 100 ug, optionally twice daily.

36. The method of claim 35, wherein the steroid is delivered in amount of at least 200 ug, optionally twice daily.

37. The method of claim 36, wherein the steroid is delivered in amount of at least 400 ug, optionally twice daily.

38. The method of claim 30, 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;

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

39. The method of claim 30, wherein the therapeutic or pharmacokinetic effect treats at least one of migraine and allergic rhinitis.

40. The method of claim 30, further including substantially closing a soft palate of the patient during the delivery step.