Generex trial for Oral-lyn

Generex may be offering an investigational new drug (IND) trial to get FDA approval for Oral-lyn here in the United States.

If this is something that may be of interest to anybody here on TuDiabetes – let me know and I will get the contact information regarding the trial.

To learn more about it, read this LA Times article:
LA Times article about Oral-lyn

Could you tell us more about the product. How long before Oral-lyn starts working? I hear it is faster postprandially. How fast? What is the peak? What is the duration? Does it have an unpleasant taste or odor? How is it possible to get exact dosages? One puff equals one unit? Might need a lot of puffs. I know you have rolled out the insulin in Ecuador, Middle East and Latin America but I have yet to hear of personal experience using this insulin. Yes, interested.

Hey Jan,

This is the reply I got from Generex when I inquired about the IND trials:

Dear Allie

As a follow up to Rose Perri conversation where you discussed the use of Generex Oral-lyn™ in the U.S.A, I am sending you information on the buccally absorbed regular recombinant human insulin product and attached fact/information sheets on the FDA approved Treatment IND program available in the United States. Additional Treatment IND information is also available at www.generextxind.com and www.clinicalTrials.gov.

Below is a brief description of the buccally absorbed insulin.

Generex Biotechnology Corp. has developed an insulin which is delivered as a spray to the oral mucosa from where it is absorbed directly into the circulation. It is a human recombinant regular insulin for prandial use and is called Generex Oral-lyn™. It is currently used by patients (Type 1 and 2) who have difficulty or cannot take injectable insulin for prandial glucose control. It is currently approved by FDA in the United States under the Treatment IND program for use by patients who have difficulty using conventional insulin treatments.

Generex Oral-lyn™ is an easy, needle-free insulin treatment for patients requiring control of prandial glucose excursions. 1 spray is approximately equivalent to 1 unit of regular injectable insulin. Even though it is a regular human insulin, it is rapid acting (behaves like an analog) due to its area of absorption. The onset of effect is within 15 min, its peak effect in approximately 30 min and total duration of effect is approximately 2 hrs. Once at baseline again, it shows no tail therefore has no stacking effect or chance of hypoglycemia. Due to its short action (total of 2 hrs) it is versatile in its uses. It is primarily intended for prandial use, however, it can also be used between meals for glucose control as long as a 2 hr window of effect is available.

Should you be interested in pursuing approval for the use of Generex Oral-lyn™ through the Treatment IND program, please contact me at the below listed contact information and we will be happy to guide and assist you through the process.

Should you have any other questions, please e-mail me at jkatsios@generex.com or phone at 416-364-2551 Ext 228.

Regards,

Jeri Katsios


I also have an attachment in the email that includes a .zip file

Thanks for this. The insulin is faster than even than Apidra. Concerned about the taste and how pleasant it is to use on a daily basis, as well as how reliable the blood glucose lowering effect is; if one spray could possibly sometimes give a little more or a little less than one unit, etc. Oral-lyn has been in use in Ecuador, Middle East, India, but I have heard nothing from the patients themselves regarding their experiences with use of this insulin. After many years of pumping there will be scar tissue, plus this seems to have a very good DIA, if information is accurate. So there is a need for this delivery system.