# US 2015/0144129 A1 · Nasal administration

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- Number: US 2015/0144129 A1
- Document ID: US20150144129A1
- Status: Published application
- Kind: A1
- Application number: 14/315,132
- Filed: 2014-06-25
- Published: 2015-05-28
- Earliest claimed: 2013-03-26
- Assignees: OptiNose AS
- Applicants: Optinose AS
- Inventors: Per Gisle DJUPESLAND; Ramy A. MAHMOUD; John MESSINA
- Web page: https://patentgrep.com/patent/US20150144129A1

## CPC

- A61M 15/08: Inhaling devices inserted into the nose
- A61M 15/0098: {Activated by exhalation}
- A61M 16/0057: {Pumps therefor}
- A61M 16/14: by mixing different fluids, one of them being in a liquid phase
- A61M 16/20: Valves specially adapted to medical respiratory devices
- A61M 11/003: {by passing the aerosol trough sieves or filters}
- A61M 15/0021: {Mouthpieces therefor}
- A61M 15/0041: {with movable piercing or cutting means}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- A61M 16/0045: {Means for re-breathing exhaled gases, e.g. for hyperventilation treatment}
- A61M 16/1055: {bacterial}
- A61M 16/107: {in the inspiratory path}
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2202/0275: Nitric oxide [NO]
- A61M 2202/0468: non-physiological
- A61M 2202/064: Powder
- A61M 2205/3324: PH measuring means
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 6)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 10)

The method of claim 10, wherein the therapeutic agent is delivered in amount of at least 75 μg daily, at least 100 μg daily, at least 200 μg daily, at least 400 μg daily or at least 800 μs daily, optionally delivered in two doses, optionally at least 37.5 μg b.i.d., at least 50 μg b.i.d., at least 100 μg b.i.d., at least 200 μg b.i.d. or at least 400 μg b.i.d.

### Claim 12 (depends on 10)

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.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 1)

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.

### Claim 16 (depends on 15)

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

### Claim 17 (depends on 1)

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.

### Claim 18 (depends on 17)

The method of claim 17, wherein delivering further comprises:
adjusting a pH at the location by controlling the fluid flow.

### Claim 19 (depends on 18)

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.

### Claim 20 (depends on 19)

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

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 17)

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.

### Claim at position 23

23-80. (canceled)