In the Pipeline: Oral Insulin

At this time in the United States, injection and infusion are the only methods available for taking insulin — but with various teams of researchers hard at work, and with noninjection forms of insulin already making their debut in certain countries, this situation may change in the future.

One product that is already available in Ecuador, India, and, on a very limited basis, Canada, is Oral-lyn, a formulation of Regular insulin that is sprayed into the mouth using a device similar to an asthma inhaler. The insulin is then absorbed through the mucous membranes lining the mouth. Oral-lyn begins lowering blood glucose levels in 5 minutes, 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. Oral-lyn is currently in Phase III trials (trials to definitively assess the drug’s effectiveness) in the United States, Canada, Russia, Ukraine, Bulgaria, Romania, and Poland. It is being developed by Generex Biotechnology Corporation and is intended for use in people with Type 1 or Type 2 diabetes.

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Oramed Pharmaceuticals, Inc., a company that creates oral methods for administering drugs typically given by injection, is also developing a noninjectable insulin. Presently in clinical trials to assess safety and effectiveness, this drug is a form of Regular insulin that is delivered in capsules that are swallowed. It will initially be intended for use in people with Type 2 diabetes. The capsules are specially formulated to avoid breakdown while in transit through the stomach. The insulin is absorbed in the intestine and then travels first to the liver.

According to the company, routing insulin to the liver first more closely mimics what normally happens in a person without diabetes than injecting or infusing insulin under the skin. The insulin signals the liver to store glucose and to refrain from releasing stored glucose to the bloodstream. This helps to lower the blood glucose level, relieving some of the burden on the pancreas to produce insulin, and therefore helping to preserve pancreatic function for longer.

Oramed Pharmaceuticals plans for the capsules to be available in select countries within the next few years and anticipates approval in the United States to follow several years later.

A set of researchers funded by the Indian government is also in the process of developing an insulin pill, which is scheduled to be studied in human trials within several months. This pill makes use of nanoparticles (extremely small particles) to deliver insulin to the bloodstream. Additional methods of insulin delivery now in the early stages of development are sublingual insulin, or insulin that is placed and absorbed under the tongue; inhalable insulin that is delivered through the lungs; and insulin suppositories to be absorbed through the lining of the rectum.

This blog entry was written by Diane Fennell, Associate Editor of Diabetes Self-Management magazine.

  • CalgaryDiabetic

    Dear Web Team.

    I like the idea of oral-lyn short duration action could be great for correcting post meal highs. The inhaled one was a bust a lady said she had poor control on it. The beauty of injecting insulin is that the phenomenon is fairly reproducible remains to be seen if other techniques can match this.

  • Tom

    Post meal has always been a problem for me. This would be a big help. When will this spray be available to the public?

  • Lynn in Greensboro NC

    This is exciting news!!! Keep us updated on the progress of the drug…

  • ccrn123

    My cousin lives in India and has been using it for two weeks now and has her blood sugars in good control. She will never go back to injections.

  • Fred

    This is wonderful news. This is such a break through for insulin users. Why can’t the FDA speed up approval? Is there any way to get it from India? I am just starting insulin and would love to get my hands on any of these products.

  • Tara Dairman, Web Editor

    Hi Fred,

    The question of whether the FDA is too cautious or too lenient is the source of some debate. You may want to check out our recent Diabetes Flashpoints post, “FDA: Stifler or Savior?” for details about the FDA’s recent tightening of standards for new diabetes drugs and the reactions of people in the diabetes community.

  • Ariyannur Sambhu Nampoothiri.Fort,TVM.

    I am having tablets 3 times daily to control my diebetes;so I,m verymuch interested to know that
    I’ll get Oral Insulin in the near future in India also at afordable rates,if so ;it’ll be a good relief to me as I can avoid the risk of the side-effects of consuming so many tablets ,sice I’m,taking other tabs for controlling my hypertension,cholestrol etc also.

  • TOM ADAMS

    ORAL INSULIN IS WONDERFUL NEWS. THE INFORMATION WE READ STATING HOW MUCH BETTER IT IS TO CORRECT
    OUR PROBLEM IS WHAT ALL OF US HAVE WANTED FROM THE FIRST SHOT.

  • Dwight

    Awesome, the sooner the better.

  • M. Dodge

    Very recently I was watching a documentary series that followed women (in the US) through their pregnancy and delivery experiences. One of the women had developed gestational diabetes and she was put on insulin tablets. The show then filmed her dispensing and taking two small pills. This was the first I had heard about oral insulin so I looked it up online. I am curious how she was able to get the medication, as everything I’ve read on it so far seems to indicate that it is not yet available. Any ideas how she might have gotten it?

  • foolad eghbali

    thanks a lot.Keep us updated please

  • dayananda salian

    i would be intersted in knowing more about oral forms of insulin ,when it will be launched in India & wht will be the cost factor.

  • Aftab Ahmed Baig

    It is realy a facinating idea that in near future
    the old and tiresome procedure of pricking for gettin insuline will be an obsolete method and diabetic patients will take there required dose of insulin by mouth in the shape of tablet or capsules. I pray that such type of drug be soon awailable commercially in the market.

  • Dr Daniel Debrouse

    Thought everyone may find this of interest as Tamarisk is considering all license opportunities, giving every company large an small an opportunity to speak with us regarding oral insulin.

    You may wish to know Oral Insulin has been released and announced by Tamarisk Technologies, LLC. We are the first in the world to develope a transport vehicle allowing oral administration at therapeutic levels with an absolute bioavailability of an incredible 91.08% of administered insulin dose. Please see full in vivo study published by Tamarisk Technologies, LLC. This can be found at http://www.tamarisktechnologies.com. Plus some other major therapeutic peptides have been orally administered and studies there of published or in process thereof. Such as PYY 3-36, EPO, TNF, Herceptin and Pegylated Interferon.

    Kind Regards,

    Dr Daniel DeBrouse

  • Pharmahyde

    Is this for real? Why isnt it in the news?

    EscMatrix

  • Dr Daniel Debrouse

    Yes it most certainly is for real with a decade of scientific data to support. Both animal and human model testing. We are currently looking to the press to take it public shouldn’t be long. Keep in mind, however, this technology is disruptive to the industry and they have said as much so public demand may certainly be warranted.

  • EscMatrix

    Looks like the Tamarisk people moved sites…

    http://www.deliv-rx.com

    Does anyone know if they have been bought out?

    EscMatrix