NEW YORK, Nov. 29 /PRNewswire/ -- THIS IS A MULTIVU SPECIAL REPORT.
THE FDA HAS JUST APPROVED A NEW, HIGHER DOSE FORMULATION OF THE PHOSPHATE BINDER FOSRENOL(R) (FOSS-WREN-ALL) FOR END-STAGE RENAL DISEASE PATIENTS WHO HAVE HYPERPHOSPHATEMIA. DR. RAJNISH MEHROTRA OF THE UNIVERSITY OF CALIFORNIA AT LOS ANGELES COMMENTS:
(Rajnish Mehrotra, M.D., Associate Professor of Medicine at the David Geffen School of Medicine at UCLA, Los Angeles and Los Angeles Biomedical Research Institute)
Compliance is a big problem in patients with end stage renal disease because of the large number of pills they have to take with every meal as phosphate binders. The new preparation of FOSRENOL(R) would allow patients to take one pill with every meal which is a substantial reduction in pill burden and has the potential to improve outcomes in phosphorus control in patients with end-stage renal disease”
ACCORDING TO EXPERTS, FOSRENOL(R), WHICH HAS DEMONSTRATED LONG-TERM EFFICACY AND TOLERABILITY IN CLINICAL TRIALS, MAY HELP SIMPLIFY THE TREATMENT OF HYPERPHOSPHATEMIA.
“Based upon our experience in clinical trials, the new formulation of FOSRENOL(R), should be effective and easy to take by most dialysis patients.”
THE MOST COMMON ADVERSE EVENTS WERE GASTROINTESTINAL, SUCH AS NAUSEA AND VOMITING, AND GENERALLY ABATED OVER TIME WITH CONTINUED DOSING. THE MOST COMMON SIDE EFFECTS LEADING TO DISCONTINUATION IN CLINICAL TRIALS WERE GASTROINTESTINAL EVENTS (NAUSEA, VOMITING, AND DIARRHEA). OTHER SIDE EFFECTS REPORTED IN TRIALS INCLUDED DIALYSIS GRAFT COMPLICATIONS, HEADACHE, ABDOMINAL PAIN AND HYPOTENSION. ALTHOUGH STUDIES WERE NOT DESIGNED TO DETECT DIFFERENCES IN RISK OF FRACTURE AND MORTALITY, THERE WERE NO DIFFERENCES DEMONSTRATED IN PATIENTS TREATED WITH FOSRENOL(R) COMPARED TO ALTERNATIVE THERAPY FOR UP TO THREE YEARS. THE DURATION OF TREATMENT EXPOSURE AND TIME OF OBSERVATION IN THE CLINICAL PROGRAM ARE TOO SHORT TO CONCLUDE THAT FOSRENOL(R) DOES NOT AFFECT THE RISK OF FRACTURE OR MORTALITY BEYOND THREE YEARS. WHILE LANTHANUM HAS BEEN SHOWN TO ACCUMULATE IN THE GI TRACT, LIVER AND BONE IN ANIMALS, THE CLINICAL SIGNIFICANCE IN HUMANS IS UNKNOWN. PATIENTS WITH ACUTE PEPTIC ULCER, ULCERATIVE COLITIS, CROHN’S DISEASE OR BOWEL OBSTRUCTION WERE NOT INCLUDED IN FOSRENOL(R) CLINICAL STUDIES. CAUTION SHOULD BE USED IN PATIENTS WITH THESE CONDITIONS. FOSRENOL(R) SHOULD NOT BE TAKEN IF YOU ARE NURSING OR PREGNANT. FOSRENOL(R) SHOULD NOT BE TAKEN IF YOU ARE UNDER 18 YEARS OF AGE. FOR MORE INFORMATION ABOUT FOSRENOL(R) PLEASE VISIT http://www.fosrenol.com.
I’M DANIELLE ADDAIR.
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