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Nazal Spray May Treat Obesity in the Nearest FutureJune 1, 2006 - Nastech Pharmaceutical Company Inc. - PYY3-36 (peptide YY) nasal spray entered the phase of necessary clinical trials aimed at receiving the approval from the American Food and Drug Administration as the obesity treatment. On June 1, 2006 Nastech Inc. announced the submission of documents to the FDA that will allow company to start Phase 1 clinical studies with its peptide YY nasal spray, which is the leading company’s product candidate for treating obesity. IND (Investigational New Drug) application is necessary to initiate the common procedure of clinical studies, containing several stages to evaluate efficiency, safety and other characteristics of a new drug before the FDA approves investigational drug for the usage on the territory of the USA. The initial study of the PYY3-36 nasal spray aims at finding out its pharmacokinetic parameters, its influence on the human appetite and food intake as well as at evaluating safety of various dosages of the nasal spray. Peptide YY is a natural hormone, which is considered to work in human digestive tract as a suppressant of appetite and food intake. Scientists believe that this hormone is secreted by the special endocrine cells (L-cells) to regulate food intake in humans. Peptide YY hormone signals the digestive system to decrease the production of stomach acid as well as to slow down stomach emptying and decrease gut motility. As the result, one does not feel hungry for a longer period of time. Taking into account that a great number of obesity cases is linked to uncontrolled or unbalanced food intake regimen, peptide YY seems to be very promising medication. There is data, showing that infusion of Peptide YY reduces food intake in humans by 33% over 24 hours. During earlier studies peptide hormone was delivered into the organism by injections. However, Nastech Pharmaceuticals Inc. developed its PYY3-36 in the form of nasal spray. The company used this method of drug administration in order to make the process of treatment as easy and comfortable as possible for all the patients. Nasal sprays seem to become the next popular method of drug delivery after oral pills. According to Nastech Inc., nasal delivery has significant advantages, such as ability to deliver wide range of therapeutics, rapid onset of action, potential for the direct delivery to the brain and avoidance of the first-pass hepatic metabolism (when a drug is consumed before it starts working). Anyway, Nastech Inc. looks with great optimism to the upcoming clinical studies of its PYY3-36 medication: "We're moving aggressively to demonstrate the potential for PYY nasal spray to treat obesity. 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." Nick External resources http://investor.nastech.com/phoenix.zhtml?c=83674&p=irol-newsArticle&ID=86998... http://www.ncbi.nlm.nih.gov/entrez/dispomim.cgi?id=600781
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08-Oct-2008 |
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