PARSIPPANY, N.J., Sept. 19 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation to PREOS(R) (parathyroid hormone [rDNA origin] for injection) for the treatment of hypoparathyroidism, a rare deficiency of parathyroid hormone for which there is no FDA-approved therapy.
Hypoparathyroidism afflicts approximately 65,000 people in the United States and an estimated 120,000 outside of the U.S. It is most often caused by injury to or removal of the parathyroid glands during neck surgery. It also occurs as an autoimmune disorder associated with HIV infection. Current treatments include vitamin D analogs and large doses of supplemental calcium to relieve the symptoms of neuromuscular irritability associated with hypoparathyroidism. Despite these palliative therapies, the absence of endogenous parathyroid hormone compromises the body's ability to properly absorb calcium. This invariably results in hypercalciuria and nephrocalcinosis, a serious condition characterized by calcium deposition in the kidneys. PREOS could potentially be a first-in-class therapy for use in this condition.
"We greatly appreciate the FDA's support of our efforts to evaluate the
use of PREOS as a hormone replacement therapy to treat hypoparathyroidism.
The results of the proof-of-concept study using PREOS in this indication
have been very encouraging, especially when compared to current palliative
therapies that often result in long-term toxicities and complications for
patients. We are excited to expand the development of PREOS beyond our
initial focus on osteoporosis to include the drug's potent
|SOURCE NPS Pharmaceuticals, Inc.|
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