Intranasal Parathyroid Hormone for Osteoporosis

Description:

Nastech has developed a nasal dosage form of Parathyroid Hormone (PTH_1-34) for the treatment of osteoporosis, which is currently only available as a once daily injectable product. This innovative new product utilizes Nastech's proprietary tight junction modulation (TJM) technology to offer a patient preferred delivery method for parathyroid hormone. PTH_1-34 is a peptide fragment (34 amino acids) of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH_1-34 has been shown to increase bone mineral density and significantly reduce fractures in both women and men suffering from osteoporosis. For example, subcutaneous injections of PTH_1-34 given with calcium and vitamin D reduced the risk of osteoporotic fractures by 65 percent, when compared to calcium and vitamin D alone. With respect to bone mineral density (BMD), daily subcutaneous injections of PTH_1-34 produced a 12 percent increase in lumbar spine BMD after 18 months of treatment. Daily injections of PTH_1-34 are approved for the treatment of osteoporosis.

Development Status:

A Phase II biomarker study was completed in 2007. It was a 28-day, multi-center study in over 250 postmenopausal osteoporotic women. The study demonstrated a dose-dependent and statistically significant increase in bone formation biomarkers and a statistically significant decrease in bone resorption markers. The doses were also well tolerated. Phase I pharmacokinetic studies of intranasal Parathyroid Hormone (PTH_1-34) have demonstrated positive results. These studies achieved their goals of demonstrating the ability to deliver Nastech’s intranasal PTH_1-34 and produce a similar pharmacokinetic profile to the currently marketed injectable product.

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 an 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 her/his remaining lifetime. The estimated national direct expenditures (hospitals and nursing homes) for osteoporotic and associated fractures was $17 billion in 2001 ($47 million per day) and the cost is rising.

Recent News:

• 07 November 2007: Nastech Reacquires Teriparatide (Parathyroid Hormone; PTH1-34) Nasal Spray from Procter & Gamble
• 26 June 2006: Nastech’s Parathyroid Hormone (PHT1-34) Nasal Spray Demonstrated Similar Exposure Levels to Approved Injectable Product in Phase I Study in the Elderly
• Read more news

External Links:

• National Osteoporosis Foundation
• International Osteoporosis Foundation
• The Osteoporosis Center