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Hormonal injection approved for treatment of hypoparathyroidism
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The FDA recently approved a parathyroid hormone product to control hypocalcemia in patients with hypoparathyroidism, according to a press release.
The parathyroid hormone being marketed as Natpara (NPS Pharaceuticals, Inc.) is a hormonal injection administered once daily to help control calcium levels. It received orphan drug designation by the FDA because it is intended to treat a rare disease.
A clinical trial of 124 participants assigned to Natpara or placebo was used to evaluate efficacy and safety. Forty-two percent of participants treated with Natpara achieved normal blood calcium levels on reduced calcium supplement doses and active forms of vitamin D compared with 3% of participants on placebo.
Rat studies have revealed a risk for bone cancer, which is indicated on the label; however, it is unclear if the risk is increased for humans.
Natpara is recommended only for patients whose hypocalcemia is not adequately controlled with calcium supplementation and active forms of vitamin D.
The drug is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.
The most common side effects reported included sensations of tingling, tickling, pricking or burning of the skin; low blood calcium; headache; high blood calcium; and nausea.
“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life,” Jean-Marc Guettier, MD, director of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluated and Research, said in the release. “This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D.”