Pfizer's bandwagon might be busted! Turns-out a study says inhaled human insulin, whether formulated as a powder or liquid, is more immunogenic than injected insulin.

Adverse effects of antibody formation have not been thoroughly investigated. But it was shown, comparatively, that inhaled insulin provokes more of an immune response than injections. Spitting is a dirty habit - but it's not good for nothing. The mucosal defense system is the body's primary line of defense against inhaled foreign matter - kind of like the MARINES of the human body. It is uniquely able to discern self from non-self bodies. So far - it looks like Pfizer's toker is a no go.

As I said before - the adverse events have not been thoroughly investigated. Until we know exactly what kind of mucosal revenge or pulmonary punishment lies ahead - I'd stick to the tried and true...subQ, for now. However the Generex Oral-lyn human trials are looking pretty promising. Stay tuned.

At the request of the Regulatory Affairs Manager at Generex, I am posting the following to defend the accuracy of the packaging and the claim of the product. The initial blog addressed a product called Glucose RapidSpray. The reader feedback, as well as the regulatory affairs response, is listed below. In no way, does Generex imply this product is to be used to treat hypoglycemia.

The comment to the original post stated:

The nutritional label on the product (available as a PDF on their web site) says the product has 188mg of carbs (or .188g) per serving (5 sprays). A typical glucose tablet has 4g... that's about 21x more carbs in a single glucose tablet than in 5 sprays of RapidSpray. Considering you typically use at least 15g of carbs to treat hypoglycemia, you would need around 80 sprays to get 15g of carbs into your system! When you take into account the amount of sprays you need, the calorie count isn't very much different from glucose tablets.

Read the label carefully, and be very careful using this!

The response from the Manager of Generex Regulatory Affairs states:

The product, Glucose RapidSpray™, is to be taken at the first sign of needing additional glucose in the diet, either between meals, during exercise, and/or before bedtime. It is not intended to take people out of full hypoglycemic states that normally a full tube of glucose gel or a full dose of Glucose tablets would be needed for. Glucose RapidSpray™ product is meant to be a complement to meals in order to help with glucose levels. As such, a direct correlation of carbs associated with Glucose RapidSpray™ and typical glucose tablets or gel is not warranted based on the intended use of the product. If usage of the product is maintained by taking Glucose RapidSpray™ at the first sign of needing additional glucose, then the Nutritional Facts stated on the package labeling is adequate for determining caloric intake (be it 5 sprays, 10 sprays, 15 sprays or whatever is taken to address the situation).

I consider the proactive response of Generex a good sign of how a company is run. Without needing to do so, Generex went above and beyond the call to address an open forum about the efficacy and accuracy of the product. This is the kind of interaction that convinces me a company cares! Good job, Generex! Lest I NOT hold my breath for Eli Lilly to return my call about Super Insulin. Novo Nordisk was far more receptive to address my interests, as a diabetic. Stay tuned for my follow-up on the Eli Lilly vs. Novo Nordisk – Who Love You, Baby!?!

The company making oral insulin a reality is distributing a teaser product to give you a hands-on example of the efficacy, ease and convenience their drug delivery system offers. Feast your buccal cavity on Glucose RapidSpray! The reality of oral-insulin is coming soon to the US - but its sugar stabilizing sister is here today!

Glucose RapidSpray can be taken at the first sign of the need for glucose, during exercise, between meals, or even before bedtime. It is simple to use and easy to carry. It comes in two different flavors, orange and raspberry, and there are no artificial colors. The main ingredient in Glucose RapidSpray is D-Glucose (dextrose), which is a simple monosaccharide sugar. Keep Glucose RapidSpray in your home, office, pocket, purse, or car (as long as it does not stay in sub-zero temperatures for too long). Interested in getting your hands on it?

The product is now available in over 2,500 stores in the United States at Aurora Pharmacy, Inc., Bi-Mart Corporation, The Diabetes Place, Fruth Pharmacy, Inc., Hy-Vee, Inc., Kerr Drug, Inc., The Medicine Shoppe® Pharmacy, Meijer, Inc., and ShopKo Stores. It is also available for purchase online at Glucose Rapid Spray and Diabetic Express.

This might be the first product from Generex you'll use, but it certainly won't be the last. Generex's flagship product is oral insulin, brand name Oral-lyn™. It is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, and is in various stages of clinical trials around the world. For more information, visit the Generex site or call 1-800-391-6755.

Sink your teeth into this one. Generex, the company that is quickly making a name for itself as the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that it has been granted the first patent for its medicinal gum platform. The patent is titled Compositions for Oral Transmucosal Delivery of Metformin. It covers claims to the composition, processes, and methodologies for the delivery of an oral transmucosal metformin composition via the oral mucosal membrane for absorption. Long story short: you chew it.

Metformin is a generic drug used to regulate blood sugar levels by reducing the amount of glucose produced by the liver. The popular brand names of Metformin include: Glucophage, Diabex, Diaformin, Fortamet, Riomet, and Glumetza. Metformin is the only anti-diabetic drug that has been proven to reduce the cardiovascular complications of diabetes, as evidenced in a large study of overweight patients with diabetes. Metformin has been in use around the world for more than 30 years. It remains the most prescribed drug for Type-2 diabetes, a testimony to its efficacy and its prominent place in diabetes therapy.

Rose C. Perri, the Generex Chief Operating Officer commented, "we are very pleased to receive the first patent for our metformin gum product, a product that compliments our flagship product, Generex Oral-lyn™, and related diabetes pipeline". On a personal note, when I first learned about this development from the masterminds at Generex I was definitely excited. But now that the train has left the station, I'm happy to share this news with the gum-chewing, metformin-taking, diabetes population. It's all about the delivery and this one is definitely special.

Generex's flagship product, Oral-lyn^TM, is an oral insulin spray for the treatment of type 1 and type 2 diabetes. Their technology permits the delivery of insulin through the oral cavity (with no deposit in the lungs). Whatever you do, don't call it an inhaler.

Oral-lyn^TM is a liquid form of human insulin that is absorbed through the buccal mucosa. Say that three times, fast. It is delivered through the RapidMist^TM device, which looks a lot like an inhaler. But because this device limits absorption to the mouth, there is no entry into the lungs. The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity which makes Oral-lyn^TM an ideal mealtime insulin, as it can be conveniently administered immediately prior to meals with little prospect of hypoglycemia. Oral-lyn^TM can be used as a preventative agent by people with pre-diabetes to delay the onset of diabetes and by patients with type-2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes.

Generex Oral-lyn^TM is expected to lead to an enormous improvement in the quality of life, with the elimination of pain and a significant increase in convenience. This will result in improved compliance with a relative decrease in complications and a significant reduction in the costs associated with treating them. Knowing now that you can non-invasively continuously monitor your blood sugars, patch on your basal rate, and puff (but not inhale) for your meals - I'm going to do my share of screaming from the hilltops to get these devices the attention they warrant.

Dear Mister FDA, please don't give any of these potential pipeline treatments any shenanigans. They deserve a bedtime story and a kiss on the forehead for the promise they bring to us in the cold, weary world of diabetes. Oh yeah-- and please put a little hustle in it! Yours truly, Allie B