Calcitonin

Calcitonin-Salmon Nasal Spray for Osteoporosis

Description:

Calcitonin-Salmon Nasal Spray provides for the nasal delivery of a synthetic calcitonin hormone for the treatment of postmenopausal osteoporosis.

Calcitonin is a hormone, a peptide 32 amino acids in length, produced by the thyroid gland that acts primarily on bone. It has been shown to prevent bone loss and fractures and to increase bone density in patients with osteoporosis. Human calcitonin has a very short half-life in the blood stream. Salmon calcitonin is 40-50 times more potent and has a longer duration of action than human calcitonin. A currently approved and marketed intranasal calcitonin has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis.

Development Status:

In February 2004, the FDA accepted Nastech's Abbreviated New Drug Application (ANDA) for marketing approval of a generic Calcitonin-Salmon Nasal Spray for osteoporosis.

Clinical Need:

In the United States, an estimated 10 million individuals have osteoporosis and almost 34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis according to the National Osteoporosis Foundation. One in two women and one in four men over age 50 will have an osteoporosis-related fracture in their lifetime. The estimated national direct expenditure (hospitals and nursing homes) for osteoporotic and associated fractures was $17 billion in 2001 ($47 million per day) and the cost is rising. The only currently available formulation of calcitonin has worldwide annual sales of nearly $400 million, of which the U.S. accounts for approximately $240 million.

Partnership Status:

Licensed by Par Pharma, Inc

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