Granted Patent
B2
US 12,576,073 · App. 17/574,901 · Granted Mar 17, 2026
Antiarrhythmic formulation
Inventors:
Michael Laird Hurrey (San Ramon, CA); Luiz Belardinelli (Palo Alto, CA); Prashanti Madhavapeddi (Fremont, CA); Carlos Schuler (Kensington, CA)
Assignee:
InCarda Therapeutics, Inc.
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Abstract
Pharmaceutical compositions comprising an antiarrhythmic agent for treatment of a heart condition via inhalation. Methods of treating a heart condition include administering by inhalation an effective amount of at least one antiarrhythmic pharmaceutical agent to a patient in need thereof. Nebulized drug product and kits are also disclosed.
Claims (28)
1 . A method of treating a subject suffering from a heart condition, comprising:
administering to said subject via inhalation a pharmaceutical composition, wherein said pharmaceutical composition comprises a cyclodextrin, acetic acid, and a therapeutically effective amount of a flecainide acetate, wherein said pharmaceutical composition is in the form of a liquid solution that comprises said flecainide acetate at a concentration from 60 mg/mL to 120 mg/mL, said cyclodextrin at a concentration of from 5% (w/v) to 50% (w/v) of said liquid solution, and a pH range from 5.5 to 6.5 when measured at room temperature.
2 . A method of manufacturing a pharmaceutical composition, wherein the method comprises combining:
(a) water;
(b) acetic acid:
(c) a pharmaceutically acceptable flecainide acetate; and
(d) a cyclodextrin,
thereby providing said pharmaceutical composition,
wherein said pharmaceutical composition is in the form of a liquid solution that comprises said flecainide acetate at a concentration from 60 mg/mL to 120 mg/mL, said cyclodextrin at a concentration of from 5% (w/v) to 50% (w/v) of said liquid solution, and a pH range from 5.5 to 6.5 when measured at room temperature.
3 . The method of claim 1 , wherein said concentration of said cyclodextrin is 10% (w/v) to 30% (w/v) of said liquid solution.
4 . The method of claim 1 , wherein said cyclodextrin is hydroxypropyl-β-cyclodextrin.
5 . The method of claim 1 , wherein said concentration of said flecainide acetate is at a concentration from 65 mg/mL to 95 mg/mL.
6 . The method of claim 1 , wherein said concentration of said flecainide acetate is about 75 mg/mL.
7 . The method of claim 1 , wherein said heart condition is atrial fibrillation.
8 . The method of claim 1 , wherein said pharmaceutical composition is administered via a nebulizer.
9 . The method of claim 1 , wherein said method comprises administering 50 mg to 250 mg of said flecainide acetate to said subject.
10 . The method of claim 1 , wherein said pH of said liquid solution is about 5.9 when measured at room temperature.
11 . The method of claim 1 , wherein said pharmaceutical composition is a nebulized solution that comprises nebulized droplets having a mass median aerodynamic diameter of from 1 μm to 6 μm.
12 . The method of claim 7 , wherein said heart condition is paroxysmal atrial fibrillation (PAF).
13 . The method of claim 7 , wherein said heart condition is paroxysmal supraventricular tachycardia (PSVT).
14 . The method of claim 1 , wherein said administration of said pharmaceutical composition results in a peak plasma concentration (Cmax) of flecainide acetate in said subject that is from 250 ng/ml to 1000 ng/mL.
15 . The method of claim 1 , wherein said method comprises administering said pharmaceutical composition for up to 10 minutes.
16 . The method of claim 8 , wherein said nebulizer is a jet nebulizer.
17 . The method of claim 8 , wherein said nebulizer is a breath-actuated nebulizer.
18 . The method of claim 1 , wherein said method comprises administering about 90 mg of said flecainide acetate to said subject.
19 . The method of claim 1 , wherein said method comprises administering about 120 mg of said flecainide acetate to said subject.
20 . The method of claim 1 , wherein said method comprises administering about 200 mg of said flecainide acetate to said subject.
21 . The method of claim 1 , wherein said pharmaceutical composition further comprises a sweetener.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 21, 2026
From: HURREY, MICHAEL LAIRD; BELARDINELLI, LUIZ; MADHAVAPEDDI, PRASHANTI; SCHULER, CARLOS
To: INCARDA THERAPEUTICS, INC.
Reel/Frame 073537/0750 →
SECURITY INTEREST
Recorded Mar 13, 2025
From: INCARDA THERAPEUTICS, INC.
To: DEERFIELD MANAGEMENT COMPANY, L.P. (SERIES C), AS COLLATERAL AGENT
Reel/Frame 070515/0140 →
SECURITY INTEREST
Recorded Dec 27, 2023
From: INCARDA THERAPEUTICS, INC.
To: DEERFIELD MANAGEMENT COMPANY, L.P. (SERIES C), AS COLLATERAL AGENT
Reel/Frame 065963/0977 →
Continuity (5)
Continuation
PCTUS2020044291
· Jul 30, 2020
Provisional Application
62881689
· Aug 1, 2019
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