International Approval for Oral Insulin

Oral Insulin Spray (Oral-lyn) for Type 1 and 2 Diabetes Approved. 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.

Additional studies of the oral insulin formulation are ongoing worldwide, and phase 3 clinical trials are slated to begin in Europe and Canada later this year.