US 12,465,564 B2
Oral and nasal compositions and methods of treatment
Stephen Paul Wargacki, Pittstown, NJ (US); and Alexander Mark Schobel, Vero Beach, FL (US)
Assigned to AQUESTIVE THERAPEUTICS, INC., Warren, NJ (US)
Filed by AQUESTIVE THERAPEUTICS, INC.
Filed on Oct. 25, 2022, as Appl. No. 17/973,345.
Claims priority of provisional application 63/271,458, filed on Oct. 25, 2021.
Prior Publication US 2023/0131450 A1, Apr. 27, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/00 (2006.01); A61K 9/70 (2006.01); A61K 31/5513 (2006.01); A61P 25/08 (2006.01)
CPC A61K 9/0043 (2013.01) [A61K 9/7007 (2013.01); A61K 31/5513 (2013.01); A61P 25/08 (2018.01)] 17 Claims
 
1. A method of administering diazepam to a subject in a fed state in need thereof for treating a seizure disorder comprising:
providing a nasal pharmaceutical formulation comprising diazepam, dehydrated alcohol, n-dodecyl beta-D-maltoside, benzyl alcohol and vitamin E;
adjusting a dose of the diazepam formulation to compensate for a food effect;
administering the adjusted dose as a first spray and a subsequent spray to a nasal cavity of the subject in the fed state in need thereof for treating a seizure disorder; and
achieving a therapeutic effect in the treatment of a seizure disorder in the subject equivalent to the therapeutic effect in a subject in a non-fed state,
wherein the first spray and the subsequent spray together contain a total dose of the diazepam that is higher than a recommended effective dose for the subject in a non-fed state.