Granted Patent B2

US 12,285,581 · App. 18/660,859 · Granted Apr 29, 2025

Inventors: Ashanthi Mathai (Bethesda, MD); Michael Frost (Warrington, PA); Serena Kim (Princeton, NJ); Franciscus Koppenhagen (Salem, NH); Seth Oringher (Rockville, MD)

Assignee: Pocket Naloxone Corp.

A61M31/00A61K9/0043A61K31/485A61M2210/0618

Abstract

Claims (33)

1. A nasal mucosal delivery device for use in treating an opioid overdose, comprising:

a handle comprising a proximate end and a distal end;

a nasal stop attached to the handle toward the distal end; and

an applicator coupled to the distal end, wherein the applicator comprises a compressible polyurethane foam, wherein the compressible polyurethane foam:

does not comprise microneedles;

is characterized by its ability to hold and release a pre-determined dose of naloxone with a relative standard deviation of less than 6%;

is configured to hold from 70 μL to 350 μL of a naloxone hydrochloride composition and to release a dose of the naloxone hydrochloride composition for treating an opioid overdose by squeezing a nostril against the compressible polyurethane foam, and

contains from 1 mg to 20 mg of naloxone hydrochloride;

wherein the nasal stop is configured to rest against an anterior naris during use and to resist further penetration of the applicator into a nasal cavity; and

wherein the distance between the nasal stop and the distal end of the applicator is from 15 mm to 30 mm.

2. The nasal mucosal delivery device of claim 1 , wherein the naloxone hydrochloride composition comprises:

a concentration of naloxone hydrochloride from 20 mg/mL to 60 mg/mL;

0.05 wt % of disodium ethylenediaminetetraacetic acid;

0.10 wt % of benzalkonium chloride;

0.15 wt % of sodium chloride;

10 nM citric acid; and

a pH from 3.5 to 5.5.

3. The nasal mucosal delivery device of claim 1 , wherein the compressible polyurethane foam is characterized by a dose proportional release of the naloxone hydrochloride composition.

4. The nasal mucosal delivery device of claim 1 , wherein the compressible polyurethane foam has a volume from 500 mm 3 to 1,500 mm 3 .

5. The nasal mucosal delivery device of claim 1 , wherein the compressible polyurethane foam has a diameter from 6 mm to 12 mm and a length from 12 mm to 30 mm.

6. The nasal mucosal delivery device of claim 1 , wherein the nasal stop has a diameter that is wider than an exterior of the nostril.

7. The nasal mucosal delivery device of claim 1 , wherein squeezing comprises holding the nostril firmly closed against the compressible polyurethane foam for from 3 seconds to 6 seconds.

8. The nasal mucosal delivery device of claim 1 , wherein squeezing comprises holding the nostril firmly closed against the compressible polyurethane foam for from 1 second to 5 seconds.

9. A method for treating an opioid overdose, comprising:

(a) inserting the applicator of the nasal mucosal delivery device of claim 1 into a nasal cavity of a nostril of a patient having an opioid overdose, wherein the nostril comprises an anterior naris, a middle turbinate, an inferior turbinate, and a nasal mucosa;

(b) bringing the nasal stop into contact with the anterior naris to situate the applicator in proximity to the middle turbinate and the inferior turbinate; and

(c) squeezing the nostril against the compressible polyurethane foam to release the dose of the naloxone hydrochloride composition from the compressible polyurethane foam and to administer the naloxone hydrochloride composition to the nasal mucosa,

to thereby treat the opioid overdose.

10. The method of claim 9 , wherein inserting, bringing, and squeezing are performed by a person other than the patient having the opioid overdose.

11. The method of claim 9 , wherein inserting the applicator comprises contacting the nasal mucosa between 15 mm to 30 mm from the anterior naris.

12. The method of claim 9 , wherein, after squeezing the nostril, releasing the nostril and removing the applicator from the nostril.

13. The method of claim 9 , wherein, while squeezing the nostril, removing the applicator from the nostril.

14. The method of claim 9 , wherein following administration to a population of patients the method provides a plasma naloxone pharmacokinetic profile characterized by a T max less than 0.3 (+10%) hours.

Assignments (3)

Continuity (5)

References Cited (182)