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news.Nastech Pharmaceutical Company has initiated a dose-ranging study designed to evaluate the pharmacokinetics, efficacy and safety of various doses of the company's obesity nasal spray, PYY(3-36).
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Because PYY is a protein, initial studies focused on PYY delivery by injection. Utilizing its proprietary drug delivery technology, however, Nastech has developed a nasal spray formulation of PYY as a unique, non-invasive treatment option for obesity.
The objective of the dose-ranging study of PYY(3-36) is to identify a dose or doses that would be appropriate for further study in a long-term phase II efficacy and safety clinical trial.
The study design is a double blind, cross-over test of multiple doses of PYY(3-36) nasal spray in 12 obese subjects. The study includes intravenous (IV) PYY and placebo treatment arms. The purpose of the intravenous arms is to confirm the pharmacodynamics of IV PYY, which in three prior studies has demonstrated an approximate 30% reduction of caloric intake at the following meal.
Subjects will be randomized to each treatment arm with approximately one week between treatments. A goal of the study is to identify nasal spray doses that result in similar caloric reduction to the intravenous dose. It is expected that this study will be completed during the fourth quarter 2006 and with a budget of approximately $400,000.