The U.S. Food and Drug Administration (FDA) has approved Oral-lyn, an insulin spray for people with Type 1 and Type 2 diabetes, for its Treatment Investigational New Drug (IND) program. This approval will allow Generex Biotechnology Corporation, developers of Oral-lyn, to provide early access to the medicine to people with serious or life-threatening Type 1 or Type 2 diabetes who have no satisfactory alternative treatments and who are not eligible for participation in the company’s ongoing Phase III clinical trial of the drug.
Oral-lyn, which is currently available in Ecuador, India, and, on a very limited basis, Canada, is a formulation of Regular insulin that is sprayed into the mouth using a device similar to an asthma inhaler. The insulin is absorbed through the mucous membranes lining the mouth and begins lowering blood glucose levels in 5 minutes. It peaks at 30 minutes and stops working at 2 hours. Unlike inhaled insulins (such as the now-discontinued Exubera), Oral-lyn does not enter the lungs, both because of the design of the device used to take it, and because users are instructed not to inhale as they spray.
Generex will be providing information about the drug’s availability on the Clinical Trials Web site. This information will include details about participating sites involved in the Oral-lyn study and doctors authorized to distribute Oral-lyn through the Treatment IND program.
For more information about Oral-lyn, see the press release from Generex.
Recently I heard of this new insulin, I looked for information and also visited my endocrinologist and it seems to very nice. The only “problem” I found is that this insulin was like 5times more expensive than the one I normally use. I hope that with time this insulin will be cheaper, until then I’ll be loyal to my actual insulin (lantus glargine).
Posted by Symposier | Sep 19, 2009 at 9:07 pmThis is news to me. I live in Canada, so I will have to check this out. Sounds like a great idea, and hopefully the prices will be reasonable in the near future.
/JT
Posted by Health Guy | Sep 23, 2009 at 11:58 amhttp://www.nahanniriverherbs.com
This would seem to be an amazing benefit to Diabetes patients when it becomes universally available. I will recommend my Uncle look out for it, as he has always hated his current injections!
Posted by Bridger5 | Sep 23, 2009 at 1:50 pmSounds like a break-thru but I’ll bet old geezers like me on Medicare won’t be able to get it if it is very expensive. There are some other new meds I would like to try but Medicare will not approve them for seniors. Great idea if it is effective!
Posted by Vonnie De Rico | Sep 23, 2009 at 2:18 pmHeard about this as well and not concerned about the cost, since convenience far outweighs it…
I didnt need a Mercedes to get me from point to A to B but I bought one anyway…
Posted by User007 | Sep 23, 2009 at 2:37 pmSymposier,
Generex’s CEO, Anna Gluskin, was recently a presenter at the Rodman & Renshaw Annual Global Investment Conference. She discussed the recently announced FDA IND program and expects 50,000 people to participate. The cost is estimated to be about $1,900/person for the year. Break that down and you would pay $36.54/week for Oral-lyn, and that is if insurance does not pay some portion of the pie, maybe the normal insulin/needle cost. Considering you would no longer have to be concerned with keeping your insulin refrigerated, having clean needles, getting the appropriate about of insulin in the needle (bad eyes, shaky hands, etc), disposing of hazardous waste needles, sticking yourself with a needle (needle phobia), getting rashes or infections at the site of injection, and a whole host of other problems, then $36.54/week might not be too expensive.
Good luck to you. I wish you all the best.
Posted by tc2000chartreader | Sep 23, 2009 at 2:53 pmhas anyone triend it in a clinical trial - my daughter is 7 and just recently diagnosed. Obviously I am waiting with baited breath to have an alternative for her from the 5 to 6 shotsa day she is getting now.
Posted by Jennifer Spector | Sep 23, 2009 at 3:55 pmBeing diagnosed at the age of 18, and having taken injections for the past 5 years, hearing about medical breakthroughs and the thought of an “oral” insulin makes me excited.
Posted by Amanda Henderson | Sep 23, 2009 at 7:52 pmI don’t believe any diabetic likes testing and ministering insulin to themselves.
I am a canadian and look forward to the day I am able to try this type of management.
Jennifer,
Here is the list of doctors conducting the Oral-lyn trials. You may want to contact them regarding the trials.
If you are satisfied how the trials are going, you may want to see if your daughter is eligible to use Oral-lyn under the FDA IND approval.
Trial link:
Posted by jt | Sep 23, 2009 at 10:22 pmhttp://clinicaltrials.gov/ct2/show/study/NCT00668850?show_locs=Y#locn
Ultimately, pumping insulin would still be much preferred by me for optimal control due to being able to vary basal dosage needs to match needs throughout day. I suppose if pumping wasn’t available this might be a preferred option for bolus doses.
Posted by Erik | Sep 24, 2009 at 12:34 pmThis idea of oral insulin is surely a highly desirable development, for several reasons, for Nigerians and Africans.
With the shortage of medical personnel, it will be very helpful to have diabetics take control of their insulin management, somehow. In addition, with the risk of HIV/AIDS and other injection-transmitted diseases, anything that reduces the usage of needles is welcome good news, in this part of the world.
Posted by Ade Tade | Sep 26, 2009 at 10:05 am