US 12,440,438 B2
Method of remotely controlling pain
Shashidhar H. Kori, Clover, SC (US)
Assigned to NOVILLA PHARMACEUTICALS, INC., Arlington, VA (US)
Filed by Novilla Pharmaceuticals, Inc., Arlington, VA (US)
Filed on Jul. 21, 2020, as Appl. No. 16/934,526.
Claims priority of provisional application 62/902,566, filed on Sep. 19, 2019.
Claims priority of provisional application 62/877,041, filed on Jul. 22, 2019.
Prior Publication US 2021/0022993 A1, Jan. 28, 2021
Int. Cl. A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 31/407 (2006.01)
CPC A61K 9/0014 (2013.01) [A61K 9/06 (2013.01); A61K 31/407 (2013.01)] 6 Claims
 
1. A method of remotely controlling pain in an affected dermatomal area comprising:
topically applying via paraspinal application a composition comprising ketorolac or salt thereof to the skin overlying the dorsal branch of a Dorsal Root Ganglion (DRG) serving the affected dermatomal area, the affected dermatomal area being present in an area of the body remote from the area of the skin to which the composition is applied, the composition comprising: (i) an effective dosage of ketorolac or salt thereof as the sole active agent in an amount of from about 1% to about 10% by weight of the composition; (ii) at least one skin-penetrating agent selected from the group consisting of choline chloride, magnesium chloride, sodium chloride, capsaicin, oleoresin, capsicum, and mixtures thereof; and (iii) one or more additional agents selected from the group consisting of a nitric oxide donor, buffers, preservatives, surfactants, water, mineral oil, squalene, propylene glycol stearate, wheat germ oil, glyceryl stearate, isopropyl myristate, stearyl stearate, polysorbate 60, polysorbate surfactants, propylene glycol, oleic acid, tocopherol acetate, collagen, sorbitan stearate, vitamin A and D, triethanolamine, methylparaben, aloe vera extract, imidazolidinyl urea, propylparaben, beta hydroxy acid (BHA), cetyl alcohol, stabilization polymers, potassium chloride, and mixtures thereof.
non-systemically delivering the ketorolac or salt thereof through the skin to the perineural space, and along the dorsal branches to the DRG and Dorsal Horn (DH); and
blocking nociceptive transmission to the affected dermatomal area.