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Question.
I have been hearing, literally for
years, that there is an oral insulin product coming soon. I guess I am
writing to ask you if there is really a non-injectable insulin product
on the near horizon or is what I have been hearing just a pipe dream?
CC San Luis Obispo, CA
Answer.
Well now more than ever your question might
be ripe for some promising news. It seems that there are several non-invasive
insulin products currently in clinical trials. This is good news, because
there currently are over 18 million diabetics in this country or close
to 7% of our population. Unfortunately, the number of people with diabetes
is climbing at a startling rate. Right now diabetes is taking close to
1 in every 7 dollars spent on health care. As the number of diabetics
rises so will their take of the total health care expenditures. Perhaps
with the successful release of one or more non-invasive insulin products
patient compliance will improve and total health care dollars spent for
the management of this illness will shrink. One can only hope.
I have listed for you five major forms of non-invasive insulin currently
undergoing clinical trials. I have also provided some information about
each form being tested. Most of this information recently appeared in
Pharmacy Practice News, August 2004.
1) Exubera is a human insulin powder from a joint effort by Pfizer/Aventis/Nektar.
The product is in phase III trials and is the closet of these five products
to being marketed. The European market has already submitted their new
drug application and it is expected that Pfizer will submit theirs shortly
to the FDA. The product is inhaled, into the lungs, before meals. It is
absorbed quickly and theoretically will reduce meal-related spikes in
blood sugar levels and improve overall glycemic control in the diabetic.
2) AERx Insulin Diabetes Management System (AERx iDMS) is a Novo
Nordisk/Aradigm product also in Phase III trials. The product is a device
that electronically guides patients to breathe optimally and once they
are doing so the device will automatically administer the insulin. The
insulin is in a liquid form and not a powder as is the case with #1.
Both 1 and 2 are being tested on Type II Diabetics or Adult Onset Diabetes.
3) Oralin, an oral insulin by Eli Lilly, is currently in Phase
I trials and has a long way to go before being marketed. This product
delivers a fine mist into the mouth where the insulin is rapidly absorbed
in the mucosal membrane of the oral cavity. That is your cheeks.
Unlike the previous two products in Phase III trials this agent is projected
to be tested on both Type I and Type II diabetics.
4) NIN-058 is a GlaxoSmithKline/Nobex product that is a pill form
of insulin. The product has a special coating that is designed to prevent
the stomach's acid and enzymes from harming the insulin. Unfortunately
little data is available as the product is just getting under way.
5) AT1391 by Altea Therapeutics is a possible option for delivering
insulin via a skin patch. Imagine! This product is in Phase I trials and
unfortunately little if any data is available at this point.
Although there are several non-invasive insulin products in the pipeline,
it is important to remember that the agents listed above will behave like
rapid acting insulin. It is still to early to know if the longer acting
insulins can be placed into a formulation that can be administered in
a non-invasive way. In addition, your skin, lungs and mucous membranes
to do not fully absorb the insulin and therefore; the dose of the non-invasive
form of insulin will have to be higher and consequently the costs will
also be significantly higher. This last fact may really limit the usefulness
of these products.
You should also know that researchers are concerned about whether lung
function might not be effected over the long-term by inhaling insulin.
To date no reports of this problem have been noted. This concern would
only be born out over long term use of such a product.
Finally, the clinical trials mentioned above have excluded smokers and
those with lung problems. So there appears to be many unanswered questions
and only time will help us fully understand the full impact of non-invasive
forms of insulin currently in the research pipeline.
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