Nasulin, an intranasal insulin product candidate to treat type 2 diabetes, from CPEX Pharmaceuticals, Inc has been shown ultra-fast onset of action in clinical trials.
A randomized 6-Way crossover study of Nasulin, saline and lispro in subjects with type 2 diabetes to determine optimum dose timing 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.
Nasulin also showed that nasal administration of up to 200 microliters per nostril was well tolerated allowing the administration of doses up to 100 IU.
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.
In both type1 diabetic patients and healthy volunteers, peak glucose metabolism rates occurred earlier with ultra-rapid acting Nasulin than with rapid acting lispro.
Nasulin’s pharmacodynamic profile indicates the nasal spary has optimum activity when glucose levels rise during a meal with less potential for hypoglycemia in the hours after the meal has ended.
The findings from this study 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 Nasulin data demonstrated that the original Nasulin concentration (1.0%) and the new concentration (0.7%) revealed proportional dose-dependent increases in insulin exposures.
“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, ” stated Dr. Lance Berman, Senior Vice President and Chief Medical Office CPEX Pharmaceuticals.
The second dose concentration of Nasulin, 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 ultrarapid time-action profile may provide treating physicians and their patients safer alternatives for controlling their diabetes.
The Diabetes Technology Meeting is the second largest scientific diabetes meeting in the United States, after the American Diabetes Association’s annual Scientific Sessions meeting. Clinicians,industry leaders, and regulatory experts from all over the world attend this conference each year.
Headquartered in Exeter, NH, CPEX Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company.
CPEX has US and international patents and other proprietary rights to technology that facilitates the absorption of drugs.
CPEX has licensed applications of its proprietary CPE-215 drug delivery technology to Auxilium Pharmaceuticals, Inc. which launched Testim, a topical testosterone gel, in 2003.
CPEX is also developing a proprietary intranasal insulin product candidate, Nasulin, which is currently in Phase 2 clinical trials.
Generex Oral-lyn has a faster onset of action and shorter duration of action than insulin delivered subcutaneously, according to a study published in the journal Diabetes, Obesity and Metabolism.
An independent review of clinical trials of Generex Oral-lyn showed that the oral insulin spray has a faster onset of action and shorter duration of action than insulin delivered subcutaneously, according to Generex Biotechnology Corporation.
In November, Danish firm Novo Nordisk A/S began first in man studies for its experimental insulin pill which pill replace the routine injection for diabetics even as India’s Biocon is completing its version of oral insulin for scheduled launch in next 18 months.
NN1952 has been designed to address some of the key challenges relating to oral insulin delivery. Furthermore, it utilises the GIPET (Gastrointestinal Permeation Enhancement Technology) formulation technology from Merrion Pharmaceuticals to facilitate insulin absorption from the gut.
Meanwhile, India’s leading biotherapeutics firm Biocon Ltd’s oral insulin pill is currently undergoing late phase human studies.
Biocon plans to begin commercial production within 18 months, stated Biocon’s managing director Kiran Mazumdar- Shaw, in an interview given to a leading newswire.
Insulin pill, IN-105, in which is in the final phase 3 stage of patient studies.
Insulin pill IN-105, if comes out successful in patient studies, will have huge potential with a certainty to become a multibillion dollar blockbuster.
Oral lyn is being marketed in some parts of the world including India by Shreya Life Sciences Pvt. Ltd, Mumbai.
Global insulin market is expected to grow 15 percent annually through 2010, predicts New York-based MarketResearch.com.
Nearly 246 million people are suffering from diabetes worldwide, according to the International Diabetes Federation. India has the highest number of diabetes patients in the world- nearly 41 million sufferers, followed by China and the U.S.