Since dialysis is not efficient at removing excess phosphorus, the mainstay of treatment in patients with hyperphosphatemia in advanced chronic kidney disease is the reduction of phosphate intake, which is usually accomplished with avoidance of foods containing high amounts of phosphate and with the use of phosphate-binding drugs taken with meals. Although quite effective, aluminum-containing antacids should not be used as phosphate-binding agents in patients with end-stage renal disease because of the possibility of aluminum-related dementia and osteomalacia (a condition where bones become soft and weak).
Iron-containing phosphate binders were under development for many years. These non-calcium containing phosphate binders [(ferric citrate (Auryxia), lanthanum carbonate (Fosrenol), sevelamer carbonate (Renvela), sevelamer hydrochloride (Renagel), sucroferric oxyhydroxide (Velphoro)] are indicated for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis or with ESRD.
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In November 2013, the United States Food and Drug Administration (FDA) approved the usage of Velphoro (sucroferric oxyhydroxide) for the treatment of patients with CKD on dialysis. Later on, in August 2014, it got a green signal from the European Medicines Agency (EMA) as well. Velphoro is a medicine used to control blood-phosphate levels in patients with long-term kidney disease and should be used with a low-phosphate diet and other treatments such as calcium and vitamin D supplements which help to control bone disease linked to kidney failure and high phosphate levels.
In September 2014, Auryxia (ferric citrate) was approved by the US FDA for the control of serum phosphorus levels in adults with CKD on dialysis. Apart from this, branded and generic version Sevelamer is available in the market, to control phosphorus levels in adults and children. Fosrenol is a phosphate binder that is indicated for use in ESRD (stage 5) receiving dialysis and, from October 2009, is also indicated in the EU for the treatment of adult patients with CKD who are not on dialysis with serum phosphate > 1.78 mmol/L (5.5 mg/dL) in which a low phosphate diet alone is insufficient to control serum phosphate levels.
Formulated as a chewable tablet, Fosrenol is available in 500mg, 750mg, and 1,000mg dosage strengths. The US FDA approved the 500mg dosage strength in 2004 and the 750mg and 1,000 mg dosage strengths were approved in 2005. In March 2009, Fosrenol was launched in Japan. An oral powder formulation was approved and made available in certain European countries in 2012. In August 2017, Lupin and Natco announced the final Abbreviated New Drug Application (ANDA) approval of Fosrenol Chewable Tablets 500 mg (base), 750 mg, and 1000 mg from the US FDA.
Other than the prescribed pharmacological therapies it is also important to maintain a diet of healthy foods that balance protein with phosphorus. These include chicken and other types of poultry, fish, nuts, beans, and eggs. Fluid retention can cause rapid weight change, so monitoring the weight is important. The patient might also need to increase caloric intake and decrease protein consumption. A diet low in sodium, potassium and other electrolytes may be needed, along with fluid restriction.
Even after the availability of approved therapies for the management of hyperphosphatemia, there is a significant unmet need. There are some limitations of approved therapies that need to be addressed such as safety and tolerability concerns, pill burden of phosphate binders.
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Original Source:- Hyperphosphatemia Market Research Report
