Finding a less invasive method of taking insulin seems to be all the rage these days. Although the once-hailed Exhubera fizzled away, researchers have not given up on the "holy grail" of oral insulin. Aside from Mannkind's Afrezza, which is delayed and controversial, there's another kind of oral insulin that might be making its mark in the diabetes marketplace... eventually.
Meet MonoSol Rx.
This New Jersey-based company has created PharmFilm, a thin, postage-sized film that can house microparticles of prescription pharmaceutical drugs, like insulin. Think of it as prescription Listerine strips — instead of freshening your breath, it lowers your blood sugar.
Pharmfilm made with insulin would allow PWDs to dose insulin simply by placing the film inside the cheek or under the tongue. The film dissolves quickly, and the insulin is absorbed transbuccally, or basically "inside the cheek," bypassing the destruction that takes place in the stomach. MonoSol Rx already has two PharmFilms that are FDA-approved and on the market: Zuplenz (an anti-nausea medication for chemotherapy patients) and Suboxone (used to treat addiction).
In 2008, MonoSol Rx joined with UK-based Midatech, a company that develops "biocompatible nanoparticles," which are tiny synthetic molecules designed to carry drugs safely through the body. Together, the companies formed MidaSol to develop a film containing insulin-bearing nanoparticles. They have just completed animal studies in primates and pigs, and results are looking good. Data from the study showed that the animals were able to receive the prescribed amount of insulin.
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One question is that a lot of folks dose insulin based on carbs, and not the other way around, so how do you stay flexible with dosing? Well, CEO Mark Schobel explains that PharmFilm is created with an even amount of insulin distributed throughout the strip. If you had a film with, say, 10 units of insulin on it, and you cut the film exactly in half, you would have 5 units. Or you could take two strips of the PharmFilm and have exactly 20 units of insulin.
"Picture a device that can read your glucose and then calculate and meter out how much length you need for X amount of insulin," Mark explains. "Being dimensionally driven like that, you only need to know how long it needs to be. You could get 80% of an inch to get what you need. If you need more, it would give you a larger size."
Hopefully this film will come with a precision cutter, so we don't have to worry about carrying around a tape measure and a pair of scissors! Mark is convinced that taking PharmFilm insulin will be much, much easier, including rapidly dissolving insulin strips, so you're not waiting around while dinner gets cold. He says, "We're finding very rapid uptake. We're not talking about an inconvenient dosing regimen. We're talking about making this medicine a 'non-event.'"
The CEO couldn't give any detailed information on the actual uptake of insulin into the blood stream, though he did say it was on par with other equivalent insulins. Whether or not this helps speed up insulin action is still TBD.
Mark is also convinced that PharmFilm insulin will work better than inhaled insulin, mostly due to "different pulmonary efficiencies" in people that make inhaled insulin results inconsistent. However, it's difficult to make any real value judgment on Afrezza at this point, considering clinical studies are just now being finalized, and we probably won't see any results until 2012.
And are you wondering if the film is going to taste just how insulin smells? Well, Mark couldn't share any specifics, but he did promise that whatever happens, they'll make taking the insulin PharmFilm a very pleasurable experience. Which is good, because I don't know how many people can handle sucking on something that tastes like a band-aid. Maybe we can petition for bacon-flavored insulin film?
In the meantime, MidaSol plans to start human clinical trials in Switzerland later this summer, once they once they receive approval on their Clinical Trial Application from Swissmedic. At this point, MidaSol is still focused on the basics of the mechanism, which is making sure they can get a significant amount of insulin into the body orally. From there, they can focus on different methods of dispensing the insulin (i.e. how to cut it up) and also the various long and short-acting insulins that could be used.
"We want to cover as many different types of patients as we can," Mark says, and it's also important that MidaSol keep things simple for patients. "We want to keep patient compliance and friendliness right up there with product efficacy. We want to make this a best-in-class oral insulin that is so necessary for patients."
Mark also says that MonoSol Rx will investigate using the same PharmFilm for another diabetes-related hormone, GLP-1. Although even farther off than oral insulin, the company hopes to show that other proteins and peptides can be absorbed through the cheek to help manage diabetes.
Hopefully the clinical trials for the PharmFilm insulin pan out... because who else thinks bacon-flavored insulin would be awesome?!