Nastech demonstrates parathyroid hormone nasal spray delivers drug in elderly patients

New York, June 26 - Nastech Pharmaceutical Co. Inc. announced phase 1 clinical trial results showing that a nasal spray dosage form of parathyroid hormone (PTH1-34) provided comparable exposure levels to the approved subcutaneous product, Forteo (teriparatide), in elderly patients.

The study was conducted in 25 healthy human subjects aged 66 to 77. Each received a single 20 ug subcutaneous injection of teriparatide followed by four successive doses of an intranasal formulation of PTH1-34 to allow for pharmacokinetic comparison in the same subject. The bioavailability of each PTH1-34 nasal spray formulation relative to the subcutaneous injection was also measured.

The PTH1-34 nasal spray formulations had bioavailability relative to the subcutaneous injection of up to 11%. All formulations tested were well tolerated and there were no clinically significant changes from baseline for vital signs, electrocardiograms, nasal examinations or laboratory evaluations.

Data on the trial was presented at ENDO 2006, the annual meeting of the Endocrine Society.

Nastech is a Bothell, Wash., pharmaceutical company.

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