Abstract: A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation can comprise one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a stabilizing compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.

Abstract: The present invention relates to GLP-1 and/or glucagon receptor agonists (for example, oxyntomodulin peptide analogs), pharmaceutically acceptable salts thereof, formulations comprising the same, and uses thereof for treating diabetes and/or obesity or associated diseases or disorders.

Abstract: Pediatric and modified release dosage forms of vitamin D compounds, and methods of making and using the same.

Abstract: Methods for treating vitamin D insufficiency and secondary hyperparathyroidism in patients having CKD comprising administering repeat doses of 25-hydroxyvitamin D are disclosed. The methods comprise administering 25-hydroxyvitamin D in an amount effective to safely raise the patient's serum 25-hydroxyvitamin D level to greater than 90 ng/ml and/or to control the patient's serum ratio of 25-hydroxyvitamin D to 24,25-dihydroxyvitamin D to less than 20.

Abstract: Pediatric and modified release dosage forms of vitamin D compounds, and methods of making and using the dosage forms, are disclosed.

Abstract: A stabilized 1,25-dihydroxyvitamin D2 composition which is particularly well suited for pharmaceutical formulations, pharmaceutical formulations of the 1,25-dihydroxyvitamin D2 composition, and a method of making the purified composition by purifying a crude 1,25-dihydroxyvitamin D2 from acetone/water, are disclosed.

Abstract: The invention relates to methods and compositions for reducing toxicity associated with administration of vitamin D3, its 25-hydroxylated and 1-hydroxylated forms, and analogs thereof.

Abstract: Methods, compositions, and kits for adjunctive therapy using 25-hydroxyvitamin D are disclosed. The 25-hydroxyvitamin D may be administered with an agent that increases the risk of hypocalcemia, such as cinacalcet or a salt thereof, and/or an anticancer agent. The adjunctive therapy is effective to treat and prevent iatrogenic hypocalcemia and/or secondary hyperparathyroidism, as well as delay cancer progression and the time to a post-treatment skeletal related event.

Abstract: Methods and compositions for reducing serum parathyroid levels in, for example, chronic kidney disease patients are disclosed. In these methods, an effective amount of a modified release formulation of 25-hydroxy vitamin D is orally administered to a patient suffering from secondary hyperparathyroidism to lower the patient's serum intact parathyroid hormone (iPTH) level, while avoiding a surge in serum total 25-hydroxy vitamin D.

Abstract: Methods of treating renal disease or treating at least one of muscle wasting, low muscle strength, or low physical function in a subject having renal disease by administering at least one tetrahydrocyclopenta[b]indole compound are disclosed. Also disclosed are methods of treating symptoms as a result of secondary hypogonadism induced by renal replacement therapy or kidney failure in a subject having renal disease by administering at least one tetrahydrocyclopenta[b]indole compound.

Abstract: Methods and compositions for treating bariatric surgery patients, and for treating or preventing complications associated with such patients, are disclosed.

Abstract: The method of treating elevated blood levels of iPTH by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering, as necessary, both Vitamin D repletion and Vitamin D hormone replacement therapies, is disclosed. The blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for 1,25-dihydroxyvitamin D without causing substantially increased risk of hypercalcemia, hyperphosphatemia or over suppression of plasma iPTH in the patient. The blood levels of 25-hydroxyvitamin D are maintained at or above 30 ng/mL between doses of Vitamin D repletion therapies, and the blood levels of 1,25-dihydroxyvitamin D are maintained in the patient's normal historical physiological range between doses of Vitamin D hormone replacement therapies.

Abstract: A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.

Abstract: Methods for treating vitamin D insufficiency and secondary hyperparathyroidism in patients having CKD comprising administering repeat doses of 25-hydroxyvitamin D are disclosed. The methods comprise administering 25-hydroxyvitamin D in an amount effective to safely raise the patient's serum 25-hydroxyvitamin D level to greater than 90 ng/ml and/or to control the patient's serum ratio of 25-hydroxyvitamin D to 24,25-dihydroxyvitamin D to less than 20.

Abstract: A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.

Abstract: Methods, compositions, and kits for adjunctive therapy using 25-hydroxyvitamin D are disclosed. The 25-hydroxyvitamin D may be administered with an agent that increases the risk of hypocalcemia, such as cinacalcet or a salt thereof, and/or an anticancer agent. The adjunctive therapy is effective to treat and prevent iatrogenic hypocalcemia and/or secondary hyperparathyroidism, as well as delay cancer progression and the time to a post-treatment skeletal related event.

Abstract: Pediatric and modified release dosage forms of vitamin D compounds, and methods of making and using the dosage forms, are disclosed.