A new pharmacokinetic study to compare Nastech’s intranasal insulin to injectable insulin and Exubera(R) (insulin human [rDNA origin]) Inhalation Powder, is set to begin. Nastech Pharmaceutical Company Inc. announced the initiation of a Phase I pharmacokinetic study designed to evaluate the safety, bioavailability and glucose response of Nastech’s proprietary, rapid acting intranasal insulin formulation. The study will compare Nastech’s intranasal formulation to an approved injectable product and to a recently approved new dosage form, Exubera(R) (insulin human [rDNA origin]) Inhalation Powder. Nastech’s insulin nasal spray could provide patients with a convenient, needle-free alternative while avoiding possible pulmonary side effects or long term toxicity associated with the inhalation of insulin.
This study is the first of several studies to select the formulation and determine the optimal insulin nasal spray dose that will be used to conduct subsequent safety and efficacy studies. This is designed as a dose ranging study in which subjects will receive a single subcutaneous injection of insulin, a single administration of Exubera(R), and several different Nastech insulin nasal spray doses on separate days. Pharmacokinetic and pharmacodynamic parameters will be evaluated as well as tolerability of the insulin nasal spray doses.
"Nastech’s initiation of human clinical testing marks a major milestone in our insulin nasal spray development program," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "This product candidate utilizes Nastech’s proprietary drug delivery technologies, which have demonstrated the ability to safely and effectively deliver large molecules through a non-invasive, intranasal route of administration. Nastech’s insulin nasal spray could offer a patient- and physician-preferred form of administration that avoids an injection and the potential safety concerns of pulmonary delivery. The convenience and privacy afforded by a device the size of a pack of gum also should promote patient compliance, which could in turn translate into better diabetes control and outcomes. We look forward to rapidly advancing this program and finding an appropriate marketing partner."
Nastech Pharmaceutical Company Inc
DID YOU KNOW:
Fast-Food Meals Bigger Than You Think: Fast-food customers who order large or super-sized meals consume about 500 calories more than they think. Given that Americans eat out an average about three meals a week, 500 uncounted calories at each one can add up very quickly. Over 100 adults were asked to estimate the calorie content of the meals they had just consumed at a variety of restaurants, including McDonald’s and Subway. The customers’ estimations were then compared to the actual calorie content. The study found that people who ate larger meals estimated they had eaten an average of 675 calories, but had actually consumed 1,188, a 513-calorie difference. In a second study, 40 undergraduates estimated the calories in 15 meals with different-size portions of chicken nuggets, french fries and Coca-cola. The students guessed that the larger meals contained roughly 1,000 calories, when in actuality they contained more than 1,300. The studies also showed that overweight people are more likely to order bigger meals than those at a normal weight. Annals of Internal Medicine September 5, 2006 USA Today September 4, 2006