Methods of reducing risk of preterm birth
AssigneeCovis Pharma GmbH
InventorsRobert Birch, Michael J. Jozwiakowski
Life of this patent
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Abstract
This disclosure generally relates to methods for reducing the risk of preterm birth in a pregnant human female patient that include subcutaneous administration of HPC. The disclosure relates in part to the discovery that subcutaneous administration of HPC is actually feasible and can result in sufficient plasma levels of HPC in pregnant patients that can reduce the risk of preterm birth.
Claims21
A method of reducing the risk of preterm birth in a pregnant human patient, comprising:
- subcutaneously administering to the posterior portion of the upper arm of a pregnant human patient a 1.1 mL dose comprising a pharmaceutically acceptable non-aqueous formulation comprising 275 mg 17-α hydroxyprogesterone caproate,
- wherein the subcutaneous administration of hydroxyprogesterone caproate provides in the patient an AUC0-t of between about 120% to about 88% compared to an AUC0-t of the patient administered the same dosage amount of hydroxyprogesterone caproate intramuscularly, and
- wherein the dose is administered weekly, beginning about 16 weeks or later of gestation.
A method of reducing the risk of preterm birth in a pregnant human patient, comprising:
- subcutaneously administering to the posterior portion of the upper arm of a pregnant human patient a 1.1 mL dose comprising a pharmaceutically acceptable non-aqueous formulation comprising 275 mg 17-α hydroxyprogesterone caproate,
- wherein the subcutaneous administration of hydroxyprogesterone caproate provides in the patient at least one of:
- a Cmax of about between about 96% to about 157% compared to a Cmax of the patient administered the same dosage amount of hydroxyprogesterone caproate intramuscularly;
- an AUC0-t of between about 120% to about 88% compared to an AUC0-t of the patient administered the same dosage amount of hydroxyprogesterone caproate intramuscularly;
- a Cmax of about 8 ng/mL;
- and
- an AUC of about 2,770 hr ·ng/mL to about 2,900 hr ng/mL, and wherein the dose is administered weekly, beginning about 16 weeks or later of gestation.
A method of reducing the risk of preterm birth in a pregnant human patient, comprising:
- subcutaneously administering to the posterior portion of the upper arm of a pregnant human patient a 1.1 mL dose comprising a pharmaceutically acceptable non-aqueous formulation comprising 275 mg 17-α hydroxyprogesterone caproate,
- wherein between about 24 to 48 hours after administration of the hydroxyprogesterone caproate dose the patient has a mean plasma concentration of about 5 ng/mL to about 12 ng/mL, and
- wherein the dose is administered weekly, beginning about 16 weeks or later of gestation.
A method of reducing the risk of preterm birth in a pregnant human patient, comprising:
- subcutaneously administering to the posterior portion of the upper arm of a pregnant human patient a 1.1 mL dose comprising a pharmaceutically acceptable non-aqueous formulation comprising 275 mg 17-α hydroxyprogesterone caproate,
- wherein the subcutaneous administration of hydroxyprogesterone caproate provides in the patient a Tmax of between about 18 hours to about 168 hours.
Dependencies are inferred from the claim text.