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news.A nasal spray treatment for osteoporosis being developed by Nastech Pharmaceutical's has posted positive results in a phase I test.
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The study achieved its goal of demonstrating the ability to deliver the drug, PTH1-34, and produce a similar pharmacokinetic profile to Forteo, an already approved subcutaneous treatment for the disorder.
The phase I study was conducted in 12 healthy human subjects between the ages of 20 and 40. Each subject received a single subcutaneous injection of Forteo followed by successive doses of Nastech’s intranasal formulation to allow for pharmacokinetic comparison in the same subject. The bioavailability of Nastech’s intranasal PTH1-34 formulation relative to the subcutaneous injection was also measured.
“We are encouraged by the results of this pharmacokinetic study, and remain on track to initiate a single six-month non-inferiority trial with a bone mineral density endpoint in 2006 as part of our clinical development program to support a 505(b)(2) submission for approval,” stated Dr Steven Quay Chairman, president and CEO of Nastech.
The company has now initiated a similar pharmacokinetic study in elderly patients.