Approximately 180,000 people are diagnosed with hypoparathyroidism every year according to NPS Pharmaceuticals. Hypoparathyroidism is a condition in the body which occurs when the parathyroid does not secrete enough of the parathyroid hormone. It is a condition which usually manifests in symptoms like tingling in the finger and the toes, mood swings, dry skin, headaches, hair loss, and memory problems.
Indeed it is a hormonal imbalance that while not life-threatening can create lead to disruption of everyday life functions. Fortunately about 40 percent of this population is able to control the condition without drug treatment through nutritional supplementation of calcium and vitamin D.
NPS Pharmaceuticals has developed their new treatment, Natpara, to assist that uncontrolled population of cases-approximately 20,000 cases. Their drug is a bioengineered version of the natural hormone that works to develop natural absorption and function of the body's use of calcium and vitamin D.
NPS Pharmaceuticals conducted a large-scale clinical trial of Natpara to determine its effectiveness and safety, as is the case with all drugs looking for approval. Their study resulted in 53 percent of patients gaining the ability to reduce their calcium and vitamin D supplements by at least 50 percent, compared with a 2 percent improvement with placebo patients.
By month #6 (24 weeks) at least 43 percent of those treated with Natpara were able to stop vitamin D therapy and required only 500 mg or less per day of calcium, compared with 5 percent of placebo patients.
So far the drug has been approved in Europe and the company is looking, of course, for FDA approval. Because a similar drug is associated with a higher risk of osteosarcoma, the FDA is being very cautious.
Still, Jeffries analyst Eun Yang said that 'it remains to be seen whether the FDA would put a black box for osteosarcoma [because that] could have potential impact on commercial uptake if approved.'
