Oral Insulin Conditionally Approved by FDA

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.

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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.

  • Symposier

    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).

  • Health Guy

    This 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
    http://www.nahanniriverherbs.com

  • Bridger5

    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!

  • Vonnie De Rico

    Sounds 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!

  • User007

    Heard 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…

  • tc2000chartreader

    Symposier,
    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.

  • Jennifer Spector

    has 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.

  • Amanda Henderson

    Being 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.
    I 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.

  • jt

    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:
    http://clinicaltrials.gov/ct2/show/study/NCT00668850?show_locs=Y#locn

  • Erik

    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.

  • Ade Tade

    This 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.

  • hoops

    I have been an investor in Generex, the company that produces Ora-lyn, since 2006. I am not diabetic, but I can state that Generex is trying to develop a national network of promotion and distribution for the treatment New Investigational Drug (IND) program. The latest information as to the availability, cost, and possible reimbursement for Ora-lyn can be obtained at [email protected]. Good luck.

  • Will

    What is the latest on this option? It’s been years since this post. I’m a new diabetic and I’m looking for alternative options. Interesting article, but I can’t find anything recent.

  • Spry

    The option is still available. Visit http://www.generextxind.com for more info.

  • Spry

    Visit generex dot com for more info.

  • saeed

    hello
    I want to buy 10 spry insolin ( ora-lyn ) for myself in iran . where i can to buy spry insolin ?
    best regard
    saeed zandi

  • Dr.M.Munirul Islam

    Is it possible to get product for Bangladesh market ? If so,we are very much interested .

  • bob shakor

    It is ideal for children. please make it available as soon as possible.
    Thanks