Nastech Pharmaceutical Company Inc. has 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 (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 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, MD, PhD 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 programme and finding an appropriate marketing partner."