Diabetes In Control. A free weekly diabetes newsletter for Medical Professionals. News and information for Medical Professionals.
Bentley Pharmaceuticals, Inc., announced that, following successful review of its Investigational New Drug (IND) application by the FDA, a phase II program is now in effect and under way evaluating Bentley’s human recombinant Intranasal Insulin Spray for the treatment of postprandial hyperglycemia in diabetics. Bentley’s intranasal method of insulin administration is designed to provide a quick and easy self-medication to improve patient compliance. In general, drugs entering the nasal cavity are readily absorbed across thebhighly vascularized nasal mucosa directly into the circulatory system, avoiding first-pass metabolism in the liver. The rapid absorption affords a fast onset of action comparable to the very rapid-acting, injectable insulin formulations.
"Using Bentley’s CPE-215 drug delivery platform, initial studies have indicated that
our intranasal insulin spray passes quickly through the nasal mucosa, delivering a larger payload compared to other non-injectable delivery systems. Further, we believe that targeting the nasal mucosa can avoid concerns for lung deposition and potential impacts on respiratory function in chronic treatment."
The U.S. phase II study is designed to enroll twenty-four patients with Type I
diabetes in a randomized single dose 4-way crossover study to determine the dose equivalency of intranasal insulin in comparison to subcutaneous insulin injections and to elucidate an optimal dosing sequence. Over the next 12 months, Bentley expects to complete phase II clinical studies for both Type I and Type II diabetic patients.
Two earlier studies conducted in Ireland with normal subjects and Type I diabetic
patients demonstrated rapid absorption from the nasal spray and the expected glucose response. Peak insulin levels were generally attained in 15 to 20 minutes, remaining elevated for approximately 1 hour; the resultant impact on glucose peaked in 40 minutes and decreased 1.5 to 2 hours after dosing. Calculated relative bioavailability of insulin using Bentley’s nasal spray formulation was in the range of 15-20% of subcutaneously injected insulin.
Bentley’s product candidate is designed to facilitate compliance by providing a stable liquid emulsion in a commercially available multi-dose delivery device which is convenient to carry and to use."
Obesity & Diabetes Week 11/21/06
=========================
Dr. Bernstein will be doing another live teleconference call soon. If you would like to ask a question or just register for the free teleconference call, just go to www.askdrbernstein.com and register. There were over 600 people on the last call. More info at www.diabetes911.net
================================
Advertisement
See clinical data on the sustained benefits of BYETTA for the treatment of type 2 diabetes. BYETTA delivers sustained glycemic control, with most patients losing weight, and simple, fixed BID dosing before morning and evening meals. Click here: