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.
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?!
LOL! Bacon-flavored insulin strips! MonoSol Rx isn’t the only firm pursuing these; Biodel Inc. also has what they are tentatively referring to as VIAtab, which their website claims is “an oral formulation of insulin designed to be administered sublingually”. Unlike the thin-strips approach, VIAtab will likely be tablets of some sort, but it’s still very early in the development phase, having only completed Phase I studies thus far. The company believes the audience for this product is primarily type 2 patients, and could lead to “increased insulin usage by the currently underserved early-stage patients with Type 2 diabetes and create better long-term outcomes for this patient population”. The objective sounds realistic, but the dosage element seems less clear, and in that regard, MonoSol Rx seems to have a better plan on how to deal with varying dosages.
Wow, I love this idea. Let’s hope it goes somewhere!
I can perhaps see this working for those with T2 where insulin resistance is a factor. For those of us who take smaller and incremental doses, it might be more of a challenge, despite the reassurances. For example, how would one measure 4 units? 5 might be too much and risk a low, where half a strip (2.5) might not be enough. How easy would it be to lose the 1/5 of a strip left over, and perhaps I could end up with a container full of partial strips. I think that the need for precision would make this option not very attractive from a practical perspective.
This sounds like a great idea. I hope they can determine a way to dose in tenths of units for those of us who are more insulin sensitive (i.e. 1:100 or so).
I’d heard that the smell from insulin was deliberate so you could tell it was leaking in a pump. But I know that smell’s been around since way before pumps, I think it’s due to preservatives in the insulin. Bacon sounds like a much better alternative!
I assume they could also provide these PharmFilms in different strengths, which would solve @kims situation. I think kids and babies would need really small doses.
Best of luck getting FDA approval for this.
Sounds like a great idea – but why not just bypass the strip and have a measured insulin-nanoparticle goop you squirt directly onto your gums?
Sounds like a great idea!
sounds really interesting. I hope they realize some people take 20-25 units of inuslin total per day!
I just checked their website and there is no mention of insulin in their pipeline strange.
@katerina – see this press clip, posted at the company’s site on May 13, 2011, detailing their oral insulin plans:
http://www.monosolrx.com/news_11/news_051311.htm
I heard about this idea – transmitting insulin through the cheek – three years ago from an endo who works with the biotech company Genesis. Just a reminder that these ideas that are oh, so fun to imagine – are just that. They’re still on the drawing board, and if they do come to fruition, years and years away. However, I can’t imagine them solving the 1/2 unit need for a low carb lunch
So I sent a link to this to my dad, an RN/FNP who, in partial retirement, works for one of those quick-care units in a chain pharmacy. I called it “most interesting insulin delivery system I’ve seen so far” and added this parenthetical above it: (bacon commentary notwithstanding)
My dad, with his very-dry, sometimes-obscure sense of humor, zeroed in on the references to bacon and the stamp-size. He wrote back:
Brings to mind several questions:
1. What are Jews, Moslems and vegetarians going to do?
2. Did they pick “bacon” because the first insulin was “pork” based?
3. Are they going to make a “forever stamp” to take care of insulin resistance?
4. If you are eating on a cruise ship or overseas will it take more “postage”?
I wrote back, OMG, Dad, you are too funny. Maybe he will ask one of his grandkids what omg means.
OMG, Lynnette – you AND your dad are too funny!
Actually, I think Allison made up the bacon-flavored idea — personal preference — but keep in mind it would just be “flavor” anyway, so still kosher?