NPS Pharmaceuticals Inc. (NPSP), the maker of rare-disease drugs, said its hormone-replacement therapy for a condition that stops the body from properly processing calcium and phosphorus reduced the need for other medicines.
NPS will submit the treatment, NPSP558, for regulatory approval next year, the Bedminster, New Jersey-based company said in a statement today. The drug would be the first hormone- replacement therapy approved by the U.S. Food and Drug Administration to treat the disorder, the company said.
The disease, called adult hypoparathyroidism, affects about 65,000 U.S. patients, the company said. People have to take large quantities of supplements to counteract the disorder, which can lead to burning and numbness in the hands, excessive nervousness, loss of memory and cramping, according to the Hypoparathyroidism Association Web site. NPS’s drug is a bioengineered replica of the missing hormone.
The results “bring us one step closer to our goal of providing hypoparathyroidism patients with a much-needed replacement therapy,” said Francois Nader, president and chief executive officer of NPS, in the statement.
NPS fell 22 cents, or 3.9 percent, to $5.39 at 4 p.m. New York time.
In the third of three clinical trials generally required for regulatory approval, 53 percent of the 90 patients taking NPSP558 were able to reduce the oral calcium supplements and active vitamin D therapy by at least 50 percent, compared with 2 percent of the 44 patients in a placebo group. The results met the study’s main goal.
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