Hey, Diabetes Community... when you're low do you reach for glucose tabs, gel, or another fast-acting remedy to treat hypoglycemia? Well, you might want to know about some notable changes happening that may impact what's available online and in local stores. But that's not all: we're also on the verge of seeing a new type of rescue glucagon hit the market soon!
Let's start with the big news on the emergency glucagon front:
Eli Lilly has just filed its long-awaited nasal glucagon for regulatory review in both the US and Europe, after years of clinical research on this first-of-its kind rescue glucagon that you simply "puff up your nose" to quickly boost blood sugar. We've also learned that Xeris Pharma has submitted to regulators its "EpiPen-style" liquid glucagon pen and hopes to get approval for that in 2019. Once approved, these may constitute the first true innovations in several decades in rescue glucagon, since the first glucagon injection kit appeared in 1961.
Woot! BG-boosting cheers to that!
On the other hand, we're bummed to learn that a leading brand of glucose tabs has been discontinued. Perrigo has announced it will stop making the popular Dex4 glucose tabs and gel that for years have graced the shelves of big chain retailers around the country. In fact, Perrigo tells us they discontinued Dex4 (no relation to the California CGM company Dexcom, btw) a "few months ago" in Spring 2018, and the company says that no more product is being shipped to stores in the USA. Once those stocks vanish, that's it.
Remember, these are the glucose tabs and gels that have been around for many years, often sold under the brand name of stores like CVS, Kroger, Target and Walmart.
We have more on these latest developments below, as well as a look at other changes in the fast-acting glucose market that our D-Community should be aware of. Read on...
Nasal Glucagon Coming Soon?
Given the complicated process of mixing and preparing the current glucagon kits, we've all been anxiously awaiting a new way to administer glucagon for years now. And now there's finally progress to report on the Lilly-owned glucagon that comes in dry powder form and is sprayed into the nose in case of severe hypos.
This is the product first developed by Locemia Solutions in Canada, which I had the opportunity to try as part of an early clinical trial in Spring 2014. Lilly acquired the investigational product in October 2015, and it's been caught up in clinical R&D since then. For the past couple years, we have seen impressive Phase III data at different conferences and been awaiting the next step toward regulatory filing.
During its earnings call on July 23, Eli Lilly announced it had finally submitted the product to both the FDA and European Union regulators. That process here in the US often takes 8-10 months, but there's no set timeline. Hopefully, we will see that come to market by the end of 2019.
Here's the low-down (pun intended):
- The 3mg dosing unit looks kind of like Flonase allergy spray, except it's a dry powder and not a mist.
- You'll just stick the tube into a nostril and push up the bottom, making the dry powder glucagon shoot into your nose where it's absorbed into the system.
- Clinical studies show most caregivers were very satisfied with the speed and ease-of-use: 97% reported they could deliver the nasal glucagon in under 2 minutes, and three-quarters could do so in 30 seconds. Almost all (96%) of caregivers found that the kit instructions were easy to understand and easy to administer (90%).
- Most recent Phase III data showed that out of 151 hypos, the nasal glucagon started working within minutes and about 96% returned to normal BGs/awakened after losing consciousness within 30 minutes; severe lows showed it bringing them to safe levels within 15 minutes.
- Adverse events were mild to moderate and transient, and included nausea and vomiting (which is known to occur with glucagon) and nasal irritation.
- The product is stored at room temperature and has a two-year shelf life (according to clinical trial data), which is pretty consistent with current glucagon kits that typically have an 18-24 month shelf life from time of manufacturing and can be stored at room temp.
- It will approved for kids and adults; clinical trials looked at ages ranging from 4 to 75.
- It's yet to be named, and that's something Lilly won't release until it gets approved by regulators.
- Likewise, pricing and cost aspects won't be announced until the time of regulatory filing.
While this yet-to-be-named Lilly nasal glucagon is a huge development, there are other notable glucagon products moving closer to commercialization.
We've seen Xeris Pharmaceuticals making progress on its first-of-its-kind stable glucagon, which would not only be a mini-injection for emergency dosing but could also be used in closed loop devices like the dual-hormone iLet bionic pancreas in development. We saw research on that at the ADA Scientific Sessions most recently in June 2018, and just recently Xeris has filed that with regulators here in the States in hopes of getting approval sometime in 2019. Zealand Pharmaceuticals and others are also working on glucagon products, and we look forward to seeing those before too long.
We reported on those developments earlier this year in our piece on Demand For Better Glucagon Products and Policies.
** UPDATE: In Summer 2018, we heard the exciting news that both of these above-mentioned products were submitted to the FDA for review. Lilly submitted the nasal glucagon in July, and later in the year Xeris submitted its first-gen rescue pen to the FDA with a planned approval date expected in June 2019.
Goodbye, Dex4 Glucose Products
As noted, it's RIP to the Dex4 tabs and liquids that were once owned by CanAm, before Perrigo acquired them in 2012.
We pressed for detail on what's behind this discontinuation decision, but couldn't get anywhere on that point.
Of course, this isn't the first time we've seen glucose tabs disappear. Old-schoolers diagnosed more than a decade ago likely remember the square, chalky-white glucose tabs once made by BD, that had an oddly creamy taste. Those went off the market about 2009, and at that time the company suggested the Dex4 tabs as an alternative -- ironic, given this latest news.
Other Fast-Acting Glucose Options
Without even getting into the multitude of liquids out there that have the same effect for many, there are still several options available for fast-acting glucose. The biggies are Trividia Health TruePlus tabs, shots and gels are still out there in larger retail pharmacies, as well as the Wal-Mart Reli-On brand, Optimum's 50-count of tablets, and the Valeant Pharmaceuticals Insta-Glucose gel that has 24g in each little tube are all available on Amazon and other online stores.
We are also fans of the "small but mighty" diabetes businesses that focus on these fast-acting products, ones that often have a D-Community member at the helm. Some of those that remain available include:
GlucoLift Tabs, made by fellow T1D peep Chris Angell in California, are still around. Angell happens to work full-time at Tandem Diabetes Care now but separately still runs his own small business selling GlucoLift tabs, that have been in high-demand for years now and have at times faced shortages or manufacturing delays. We're excited to know these multi-flavored tablets will remain an option!
Elovate 15 Powder was developed by North Carolina D-Mom Pam Heyward, who back in 2014 created a dry packet of glucagon powder that quickly dissolves in your mouth (or in water, if that's your preference). These individual packets of 15g are gluten-free and come in several different flavors, and are very portable and flat if that's what you happen to be searching for. For Summer 2018, the company Diasan that makes Elovate 15 is offering a 44.5% off deal for larger orders of its slim-pack glucose powder products, so now's the time to order!
Transcend Foods Gels come from another T1D-peep, Ethan Lewis from Florida, who created his fast-acting glucose company years ago, originally named GlucoBrands. It transitioned to Level Life and is now named Trascend Foods to represent how it offers both glucose gels and protein bars. These gel pouches have 15g each and are also very handy to carry; over the years, the makers refined them to eliminated the potential for the leakage, yet to be easily torn open when needed. We've been a fan over the years, and have regularly this team at diabetes and health conferences showing off their products.
Glucose Gel Necklace - anyone remember that idea of a wearable necklace with glucose gel inside? It came from fellow T1D Kris Maynard in Washington, a first responder EMT and athlete who wanted to make an easier fast-acting glucose solution. He came up with the so-called "Glucose Revival" necklace in 2016, and has been working on it since. Now, he tells us that with much support from the D-Community, he's moving forward with this "medical alert necklace with a purpose" for all people and pets (!) with diabetes. He recently started production with a plan to launch in November, so stay tuned for that!
Everyday Glucose is one you may also remember from several years back, from yet another fellow type 1 named Scott Bissinger in Boston. He created a small D-biz to make glucose tablets and also carrying cases for them. As it turns out, plans have changed. Scott took a job with diabetes data company Glooko a few years ago and while he's still running Everyday Glucose separately, his little company got out of the glucose tab arena.
Instead, they've released a Tabs2Go case for glucose tabs, but you have to provide the tabs yourself. Each slim little case holds 4 glucose tablets, and dangles on a keychain ring. Scott also says they have a large amount of surface area so can be decorated with stickers. "We've sold a few thousand to date both directly to people with diabetes and via bulk orders where the Tabs2Go case was used as a giveaway item. In particular, the case has been a huge hit with the diabetes Instagram community," he tells us.
Bissinger says after Labor Day 2018, he plans to launch a crowdfunding campaign in order to develop a new pink case that many have requested. "I'm hopeful the pink Tabs2Go cases will help even more people be prepared for lows on the go in style," he says.
So that's the state of affairs in the fast-acting glucose world, as of now.
We're never happy to hear of products exiting the market, leaving us with one less choice... but we are pleased to know we're at a game-changing point for new emergency glucagon products. And it's certainly good that many options remain available for our D-Community.