OPKO Presents Data on RAYALDEE® at ASN Kidney Week 2016
Nov 17, 2016 13:45:09 GMT
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Post by Deleted on Nov 17, 2016 13:45:09 GMT
MIAMI, Nov. 17, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK), announced that data on RAYALDEE (calcifediol) extended-release capsules as a treatment for secondary hyperparathyroidism (SHPT) in stage 3 and 4 chronic kidney disease patients with vitamin D insufficiency will be presented later today in a poster presentation at the American Society of Nephrology Kidney Week Meeting, underway in Chicago, IL.
The data showed that RAYALDEE has similar effectiveness and safety in controlling SHPT in both African-American (AA) and non-African-American (nAA) patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (defined as serum total 25-hydroxyvitamin D levels less than 30 ng/mL). Serum total 25-hyrdroxyvitamin D levels showed a similar increase in both patient populations beyond the target of 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines, despite the well established tendency for lower levels in AA patients. Plasma intact parathyroid hormone (iPTH) levels were effectively suppressed by RAYALDEE in AA patients and nAA patients versus placebo treatment.
OPKO's poster presentation entitled "Extended-release Calcifediol is Effective in African-American and Non-African-American Patients with Stage 3-4 CKD, Secondary Hyperparathyroidism and Vitamin D Insufficiency," will be presented by senior author Stuart M. Sprague, DO, Chief, Division of Nephrology and Hypertension, NorthShore University Health System - University of Chicago, Pritzker School of Medicine.
Session details:
Date: Thursday, November 17, 2016
Time: 10:00 a.m. - noon Central time
Location: Exhibit Hall, McCormick Place Convention Center
Poster Board: 512
Abstract Link: www.abstracts2view.com/asn_2016/view.php?nu=5118&type=abstract
About RAYALDEE
RAYALDEE (calcifediol) extended-release capsules is approved by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adult patients with stage 3 or 4 CKD and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. RAYALDEE has a patented formulation and is designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated iPTH. OPKO expects to launch RAYALDEE in the U.S. through its dedicated renal sales force in November 2016. The full prescribing information for RAYALDEE is available at www.rayaldee.com.
Potential side effects of RAYALDEE include hypercalcemia (elevated serum calcium), which can also lead to digitalis toxicity, and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed by RAYALDEE to abnormally low levels. Severe hypercalcemia may require emergency attention; symptoms of hypercalcemia may include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss. Digitalis toxicity can be potentiated by hypercalcemia of any cause. Excessive administration of RAYALDEE can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of iPTH. Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting. Patients concomitantly taking cytochrome P450 inhibitors, thiazides, cholestyramine, phenobarbital or other anticonvulsants may require dose adjustments and more frequent monitoring.
The most common adverse reactions in clinical trials (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
The data showed that RAYALDEE has similar effectiveness and safety in controlling SHPT in both African-American (AA) and non-African-American (nAA) patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (defined as serum total 25-hydroxyvitamin D levels less than 30 ng/mL). Serum total 25-hyrdroxyvitamin D levels showed a similar increase in both patient populations beyond the target of 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines, despite the well established tendency for lower levels in AA patients. Plasma intact parathyroid hormone (iPTH) levels were effectively suppressed by RAYALDEE in AA patients and nAA patients versus placebo treatment.
OPKO's poster presentation entitled "Extended-release Calcifediol is Effective in African-American and Non-African-American Patients with Stage 3-4 CKD, Secondary Hyperparathyroidism and Vitamin D Insufficiency," will be presented by senior author Stuart M. Sprague, DO, Chief, Division of Nephrology and Hypertension, NorthShore University Health System - University of Chicago, Pritzker School of Medicine.
Session details:
Date: Thursday, November 17, 2016
Time: 10:00 a.m. - noon Central time
Location: Exhibit Hall, McCormick Place Convention Center
Poster Board: 512
Abstract Link: www.abstracts2view.com/asn_2016/view.php?nu=5118&type=abstract
About RAYALDEE
RAYALDEE (calcifediol) extended-release capsules is approved by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adult patients with stage 3 or 4 CKD and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. RAYALDEE has a patented formulation and is designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated iPTH. OPKO expects to launch RAYALDEE in the U.S. through its dedicated renal sales force in November 2016. The full prescribing information for RAYALDEE is available at www.rayaldee.com.
Potential side effects of RAYALDEE include hypercalcemia (elevated serum calcium), which can also lead to digitalis toxicity, and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed by RAYALDEE to abnormally low levels. Severe hypercalcemia may require emergency attention; symptoms of hypercalcemia may include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss. Digitalis toxicity can be potentiated by hypercalcemia of any cause. Excessive administration of RAYALDEE can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of iPTH. Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting. Patients concomitantly taking cytochrome P450 inhibitors, thiazides, cholestyramine, phenobarbital or other anticonvulsants may require dose adjustments and more frequent monitoring.
The most common adverse reactions in clinical trials (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.