Dosage regimen for a controlled-release PTH compound
AssigneeAscendis Pharma Bone Diseases A/S
InventorsLars Holten-Andersen, Kennett Sprogøe, David Brian Karpf
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AssigneeAscendis Pharma Bone Diseases A/S
InventorsLars Holten-Andersen, Kennett Sprogøe, David Brian Karpf
Estimating the term…
The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said pharmaceutical composition is administered no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.
A method of treating or controlling hypoparathyroidism in a mammalian patient, comprising the step of administering a pharmaceutical composition comprising at least one controlled-release parathyroid hormone (PTH) compound or a pharmaceutically acceptable salt thereof by subcutaneous injection no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to 20-40% of the molar equivalent dose of PTH 1-84 administered subcutaneously every 24 hours, which is required to maintain a serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period in humans and wherein the controlled release PTH compound is of formula:
Dependencies are inferred from the claim text.