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news.Nastech Pharmaceutical has submitted an application to the FDA seeking the go-ahead to commence testing in humans of PYY3-36 nasal spray, the company's lead investigational product candidate for treatment of obesity.
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The study included in the investigational new drug application is designed to evaluate the pharmacokinetic parameters, appetite, food intake and safety of various dosing regimens of PYY nasal spray in obese subjects.
The objective of study is to determine the optimal dosing regimens that will be used to conduct a phase II clinical study based on the successful completion of this initial trial.
“We’re moving aggressively to demonstrate the potential for PYY nasal spray to treat obesity,” stated Dr Steven Quay, chairman, president and CEO of Nastech, “positive phase II safety and efficacy data would be the basis for establishing a collaboration with a major pharmaceutical company for the remaining development and commercialization of PYY nasal spray.”