Nastech submits ANDA for calcitonin nasal spray

Published: 5-Jan-2004

US-based drug delivery company Nastech Pharmaceutical has submitted an Abbreviated New Drug Application (ANDA) to the US FDA for calcitonin-salmon nasal spray.


US-based drug delivery company Nastech Pharmaceutical has submitted an Abbreviated New Drug Application (ANDA) to the US FDA for calcitonin-salmon nasal spray.

Calcitonin is a hormone produced by the thyroid gland that inhibits bone removal by osteoclasts, and promotes bone formation by osteoblasts. A currently approved and marketed intranasal calcitonin has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis. Human calcitonin has a very short half-life in the blood stream and therefore the longer acting salmon calcitonin is used therapeutically.

The global osteoporosis pharmaceutical market is currently estimated at $7bn and is expected to grow to $14bn by 2011. The only currently available formulation has worldwide sales of nearly $400m, of which the US accounts for approximately $240m.

  

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