Oral Insulin Spray (Oral-lyn) for Type 1 and 2 Diabetes is approved for use in Ecuador. On May 3, the Ecuadorian Ministry of Public Health approved the first oral spray formulation of insulin (Oral-lyn, made by Generex Biotechnology Corp.) for the treatment of type 1 and 2 diabetes mellitus. The approval is expected to pave the way for similar approvals worldwide. See more by clicking here
Oral Insulin Spray (Oral-lyn) for Type 1 and 2 Diabetes in Ecuador
On May 3, the Ecuadorian Ministry of Public Health approved the first oral spray formulation of insulin (Oral-lyn, made by Generex Biotechnology Corp.) for the treatment of type 1 and 2 diabetes mellitus. The approval is expected to pave the way for similar approvals worldwide.
The device delivers insulin for buccal absorption with no lung deposition. According to a company news release, the oral formulation is intended to offer a safe, simple, convenient, fast, and effective alternative to prandial insulin injections.
The approval was based on the results of clinical trials involving more than 250 patients with diabetes, showing that use of the product yielded insulin and blood glucose levels consistent with those achieved by injected insulin.
Since 1995, Generex has been conducting studies on buccally absorbed insulin formulations. Studies have followed a standard clinical path and have included animal trials, trials in healthy volunteers, and trials in people with type 1 and type 2 diabetes.
Generex’s clinical trials, conducted on over 250 people, have been strongly positive. The data shows that insulin and blood glucose levels following the administration of Oralin via our RapidMist device are consistent with levels achieved by injected insulin. (See more on study below)
Generex Biotechnology’s Oral-lyn(TM) Matches Fast-Acting Insulin in Phase IIb Study
Clinical Trial of Patients with Type-1 Diabetes Shows Company’s Mouth-Delivered Formulation Performing on Par with Multiple Daily Injections –
Generex Biotechnology Corp (Nasdaq: GNBT), a leader in the area of buccal drug delivery, reported today results of a recently completed Phase IIb clinical study of Oral-lyn(TM) in which Oral-lyn(TM) successfully replaced rapid-acting insulin in patients with type-1 diabetes mellitus.
This is the first report in which patients with type-1 diabetes, using glargine insulin (Lantus(R)) as their baseline therapy, have been maintained with optimal control using a schedule of meal oral insulin — Generex’s Oral- lyn(TM) — during a period of 9 days. Unlike injection or various pulmonary delivery methods (in which a powdered or liquid insulin formulation is inhaled into and absorbed by the lungs), Oral-lyn(TM) is delivered as a fine spray to the buccal (oral) cavity via the Company’s proprietary Rapidmist(TM) delivery system. The result is rapid insulin absorption through the buccal mucosal lining of the mouth without pulmonary (lung) exposure or the pain and inconvenience of needles.
"This study demonstrates that patients with type-1 diabetes who manage their disease on a daily basis using Oral-lyn(TM) and their usual long-lasting injectible insulin overnight were able to maintain glucose levels in the same fashion as they were using daily mealtime injections," said Dr. Gerald Bernstein, Generex’s Director of Medical Affairs. "Clearly, the ease and convenience of the administration of Oral-lyn(TM), combined with its ability to reproduce the effects of daily injections, can offer a profound increase in the quality of life of many patients with type-1 diabetes."
A Close Match in Glucose Control Results
The open-label, single-center trial was conducted to find the optimal therapeutic regimen of Oral-lyn(TM) and to establish the protocol for the formulation’s use in a much larger upcoming multi-center, multi-jurisdictional phase IIb/III study.
The trial involved 10 patients who had been receiving multiple daily injections (four to six). Two of these injections were basal glargine insulin administered as a two-thirds dose in the morning and one-third dose in the evening. All 10 patients received rapid insulin as their pre-meal insulin in an average of 3 to 4 injections per day (5-6 injections/day including the baseline treatment with glargine) for three days. They then received Oral- lyn(TM) as their exclusive meal insulin for nine days. The meal Oral-lyn(TM) was given as a split dose equally divided before and after each meal. Corrections with either rapid insulin or Oral-lyn(TM) were allowed at mid- morning, mid-afternoon or before the bed-time snack.
Nine-point glucose profiles were determined each day for further comparison. Fructosamine, a well-known parameter of glucose control in mid- term periods was also determined at the beginning and end of the study period.
A comparison of the daily nine-point glucose profile of each patient between the Oral-lyn(TM) regimen and injected regular human insulin indicated that Oral-lyn(TM), administered as a pre-meal insulin in a divided dose schedule, produced glucodynamic profiles comparable to that produced by injected regular human insulin (see chart). Fructosamine levels displayed a tendency to lower values with the Oral-lyn(TM) therapy at the end of the trial indicating the better control attained during the study period.
Information for this article came from the Generex website and Investors Notes.