	US 12,011,502 B2
	Compositions and methods of administering baclofen
Leonard O'Mahony, Westmeath (IE); John Devane, Dublin (IE); Sharon Hamm, Odessa, FL (US); and David Penake, Atlanta, GA (US)
Assigned to AMNEAL PHARMACEUTICALS LLC, Bridgewater, NJ (US)
Filed by AMNEAL PHARMACEUTICALS LLC, Bridgewater, NJ (US)
Filed on Nov. 9, 2022, as Appl. No. 17/984,001.
Application 17/984,001 is a continuation of application No. 17/525,298, filed on Nov. 12, 2021, granted, now 11,523,984.
Prior Publication US 2023/0201107 A1, Jun. 29, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/197 (2006.01); A61K 9/00 (2006.01)

CPC A61K 9/0019 (2013.01) [A61K 31/197 (2013.01)]

12 Claims

1. A method of treating spasticity in a patient comprising:

administering by intramuscular administration to the patient an injectable pharmaceutical formulation comprising:

an effective amount of 4-amino-3-(4-chlorophenyl) butanoic acid (baclofen), and one or more pharmaceutically acceptable excipients;

wherein the effective amount of baclofen is 20 mg;

wherein the injectable formulation has a concentration of 4 mg/mL baclofen;

wherein intramuscularly administering a 20-mg dose of the formulation to the patient produces a C_{(max)(baclofen)}value of from about 257 ng/mL to about 478 ng/mL; and

the formulation on administration to a patient provides a bioavailability that is not more than 10% different from an oral dose with similar strength.