Nasal Insulin Spray Moving Forward with Phase 2 Trials

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. Bentley Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that, following successful review of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration, 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 Chief Medical Officer Robert Stote said, "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 the highly 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 initial phase II studies have been planned and are being carried out in Texas at the Diabetes and Glandular Disease Clinic of San Antonio, P.A. under the direction of Sherwyn Schwartz as Principal Investigator. Schwartz stated, "Nasal insulin has the potential of helping a lot of people, particularly those who are afraid of needles or who have lung disease."

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.