US 11,666,573 B2
Dosage regimen of paliperidone palmitate extended-release injectable suspension
Youxin Li, Shandong (CN); Chunjie Sha, Shandong (CN); Fengjuan Zhao, Shandong (CN); Changbing Tu, Shandong (CN); Kaoxiang Sun, Shandong (CN); Wanhui Liu, Shandong (CN); Lifang Sun, Shandong (CN); and Ying Meng, Shandong (CN)
Assigned to Geneora Pharma (Shijiazhuang) Co., Ltd., Shijiazhuang (CN)
Appl. No. 16/759,287
Filed by Geneora Pharma (Shijiazhuang) Co., Ltd., Shijiazhuang (CN)
PCT Filed Oct. 26, 2018, PCT No. PCT/US2018/057858
§ 371(c)(1), (2) Date Apr. 24, 2020,
PCT Pub. No. WO2019/084501, PCT Pub. Date May 2, 2019.
Claims priority of provisional application 62/647,333, filed on Mar. 23, 2018.
Claims priority of provisional application 62/578,082, filed on Oct. 27, 2017.
Prior Publication US 2020/0297729 A1, Sep. 24, 2020
Int. Cl. A61K 31/519 (2006.01); A61K 9/00 (2006.01)
CPC A61K 31/519 (2013.01) [A61K 9/0019 (2013.01)] 17 Claims
 
1. A dosing regimen for administering paliperidone palmitate to a patient in need of treatment of schizophrenia or schizoaffective disorders, the dosing regimen consisting of:
(1) administering intramuscularly to the patient an initial loading dose of 312 mg-468 mg paliperidone palmitate on the first day of treatment; and
(2) beginning on the 29th day±7 days from the initial loading dose, administering intramuscularly to the patient at least one monthly maintenance dose in the range of 39 mg to 234 mg paliperidone palmitate, wherein each dose of paliperidone palmitate is formulated in an aqueous suspension formulation.