US 12,257,224 B2
Methods of administration for highly water-soluble salts of a short acting phenylalkylamine calcium channel blocker
Francis Plat, Saint-Laurent (CA); and Douglas Wight, Saint-Laurent (CA)
Assigned to Milestone Pharmaceuticals Inc., Montréal (CA)
Filed by Milestone Pharmaceuticals Inc., Saint-Laurent (CA)
Filed on Jul. 15, 2022, as Appl. No. 17/865,697.
Claims priority of provisional application 63/276,238, filed on Nov. 5, 2021.
Claims priority of provisional application 63/222,174, filed on Jul. 15, 2021.
Prior Publication US 2023/0065401 A1, Mar. 2, 2023
Int. Cl. A61K 31/277 (2006.01); A61K 31/7048 (2006.01); A61K 31/7076 (2006.01); A61K 45/06 (2006.01); A61K 47/18 (2017.01); A61P 9/06 (2006.01)
CPC A61K 31/277 (2013.01) [A61K 31/7048 (2013.01); A61K 31/7076 (2013.01); A61K 45/06 (2013.01); A61K 47/183 (2013.01); A61P 9/06 (2018.01)] 22 Claims
 
1. A method of treating a cardiac arrhythmia in a subject in need thereof with a therapeutically effective amount of compound I having a structure according to the formula:

OG Complex Work Unit Chemistry
the method comprising nasally administering to the subject (i) a first dose, and (ii) a second dose of an aqueous composition comprising a pharmaceutically acceptable acetate or methanesulfonate salt of compound I, or a racemate or enantiomer thereof, wherein the acetate or methanesulfonate salt of compound I, or the racemate or enantiomer thereof, is dissolved in the aqueous composition at a concentration of 350 mg/mL±50 mg/mL, wherein the second dose of the compound is administered between 8 minutes and 16 minutes after the first dose, wherein the first dose and the second dose are the same, and wherein the first and the second dose each comprises between 60 mg and 80 mg of compound I.