CPEX Pharmaceuticals to feature Nasulin at the Diabetes Technology Meeting

Nov 6 2009

CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that its intranasal insulin product candidate, Nasulin^TM, will be featured in an oral presentation and four abstracts at the Ninth Annual Diabetes Technology Meeting, November 5-7, 2009 at the Hyatt Regency Airport in San Francisco, California. Dr. Lance Berman, Senior Vice President and Chief Medical Officer, is scheduled to deliver an oral presentation entitled “The Technology and Clinical Aspects of Nasal Insulin Therapy” at 9:30 a.m. PST on Saturday, November 7. Further details on the abstracts are provided below.

A Randomized 6-Way Crossover Study of Nasulin^TM, Saline and Lispro in Subjects with Type 2 Diabetes to Determine Optimum Dose Timing
A similar glucose-lowering effect may be achieved by administering Nasulin either just before or at the end of the meal offering more flexibility of dosing than with injectable insulins.

Two Randomized Crossover Glucose Clamp Studies of Nasulin^TM and Lispro
In both Type1 diabetic patients and healthy volunteers, peak glucose metabolism rates occurred earlier with ultra-rapid acting Nasulin than with rapid acting lispro. The pharmacodynamic profile indicates Nasulin has optimum activity when glucose levels rise during a meal with less potential for hypoglycemia in the hours after the meal has ended.

Dose-Exposure for Single and Dual Nostril Administration of Nasal Insulin (Nasulin^TM)
The findings from this study demonstrated significantly enhanced insulin absorption when a 50 IU dose is administered as 2 sprays of 25 IU given in the same nostril rather than one spray in each nostril. In addition, the study also demonstrated that nasal administration of up to 200 microliters per nostril was well tolerated allowing the administration of doses up to 100 IU. Together these findings provide an improved dosing methodology and a higher maximum dose for evaluation in future clinical trials.

Dose-Exposure for Two Dose Strengths of Nasal Insulin (Nasulin^TM)
These data demonstrated that the original Nasulin concentration (1.0%) and the new concentration (0.7%) revealed proportional dose-dependent increases in insulin exposures.

Dr. Berman commented, “The data from these studies provide important information on Nasulin’s ability to rapidly lower glucose following a meal. With the completion of each study, we gain additional insight into the potential benefits Nasulin could offer to patients with diabetes. The most exciting aspect of these results is the second dose concentration, which will provide subjects in future clinical trials with a wider dose range to individually titrate their insulin needs to maximize glucose reduction without increasing the risk of hypoglycemia. These potential advantages of Nasulin’s ultra-rapid time-action profile may provide treating physicians and their patients safer alternatives for controlling their diabetes.”

Source CPEX Pharmaceuticals