13) Observation of these changes in the present study population provided confidence that a finding of "no difference" between Phoslyra and PhosLo Gelcap formulations could not be attributed to methodological flaws in trial design and/ or conduct.
PhosLo Gelcaps (calcium acetate) is an approved, effective, oral phosphate binder that is routinely used as a treatment option for hyperphosphatemia in patients with ESRD.
The primary objective of this study was to demonstrate bioequivalence between the novel calcium acetate oral solution (Phoslyra) and PhosLo Gelcaps in healthy volunteers with respect to serum P levels and urinary calcium (Ca) excretion.
The study was designed as a randomized, controlled, 3-arm open-label, cross-over Phase I study to demonstrate the bioequivalence of Phoslyra to PhosLo Gelcaps in healthy subjects.
The treatment sequences were ABC, BCA, and CAB, where A was Phoslyra, B was PhosLo Gelcaps, and C was calcium citrate (Figure 1).
received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for calcium acetate capsules, the generic equivalent of Phoslo Gelcaps.
Phoslo Gelcaps are indicated for hyperphosphatemia in patients with end-stage kidney disease who are on dialysis.
However, phosphate binders Renagel (sevelamer hydrochloride), Renvela (sevelamer carbonate), Fosrenol (lanthanum carbonate) and Phoslo Gelcaps
(calcium acetate) all show low patient compliance due to low efficacy and safety profiles, common side effects such as gastrointestinal intolerance, a high pill burden, and a high expense of therapy.