Remember that clinical trial that Mike was part of last April, that involved Puffing Glucagon Up Your Nose?
Well, the Canada-based makers of that exciting no-needle emergency rescue glucagon have come out of stealth mode, with a brand-new website for the company called Locemia (a mashup of “low blood sugar” and “hypoglycemia”), announcing their mission to spread awareness about hypoglycemia and “expand the community of people around those who use insulin to feel confident come to the aid of someone having a low.”
“We want to make it easy for everyone to be able to help anyone who uses insulin anywhere, anytime,” says Locemia co-creator and chairman Robert Oringer, an entrepreneur with a long history in the diabetes industry.
Last week at the ATTD Conference in Paris, they announced results of Phase 3 adult clinical trials “showing that this new, user-friendly, needle-free nasal glucagon delivery system is as effective as the traditional injected form of glucagon.” The research was supported by Helmsley Charitable Trust and T1D Exchange, which helped coordinate with a network of research centers around the country.
Let’s be clear: THIS IS HUGE for the roughly 7 million people in the U.S. who take insulin. How many of us live in fear of traditional glucagon rescue kits? Not to mention our loved ones, who in case of emergency, will actually have to figure out how to mix up that chemical jumble and then stab us with that gi-normous needle? Most of us leave those bright red or orange kits at home when we travel, and heck, they’re often expired anyway, so who knows if they’re effective?
Locemia wants to change all that.
Mission: Easy Help
As Mike reported, the solution is a simple nasal spray bottle, with a button to push at the bottom to activate it – kind of like Flonase spray, except the contents are dry rather than a mist. But it’s not a “product” yet, as it’s still under development while further studies, including pediatric trials, are underway. The small company hopes to make an FDA submission by the end of 2015, says Dr. Claude Piché, Locemia’s co-creator and CEO.
Oringer and Piché, along with chief commercial officer Martin LaFontaine, have been working on this solution for over 5 years, they tell us. “We’ve had no public voice, no presence at all. Announcing these research results is a big first step for us. Now we have evidence that this alternative approach -- simple as a puff in nose -- works!” Oringer says.
He talks about patient-centered design and explains that in the case of emergency glucagon, the product is prescribed to an insulin user, but they’re not actually the ones using it. Right, when you pass out from a low, someone nearby – a family member, school teacher, sports coach, or even a bystander – needs to know what to do and how to do it, quickly.
“So it’s more like caregiver-centered design. It has to start in the doctor’s office – they have to be willing to talk about hypos and this device,” Oringer says. That should be an easy sell, as it’s so darn complicated to teach the current glucagon kit. A needle-free, injection-free option? Yes, please!
Fellow D-blogger and advocate Scott Johnson tells us he's enrolled in a current use study, meaning he and his wife have the product stashed in a few locations around the house, plus one in his pocket and in his wife's purse.
"It gives her great peace of mind because it's easy and she can actually help me if necessary. She says the traditional kit is too complicated and she wouldn't be able to do it when panicked. She no longer worries about being helpless," he says. "And... I didn't experience any nausea or side effects from either (nasal or muscle) during my in-clinic study. I have not yet used it outside of the clinic."
The T1D Exchange research announcement calls Locemia’s solution “a potentially life-changing advance,” and indeed it is.
Current glucose emergency kits are not only incredibly difficult to use, but the contents actually freeze at 32 degrees because it’s liquid (a big deal for Oringer, who lives in Canada with his two type 1 sons who both play hockey). Locemia’s product would work at any temperature, he says.
It will also be sold for single-dose use, like current kits, but the shelf life should be somewhat longer than the traditional two years for the needle version. In a side note, Oringer tells us that some CDEs they’ve been training say they actually celebrate with patients when their kit expires, because it means two whole years without a severe low. Nice approach!
But cost is another factor. Heath insurers understand the value of these emergency kits even if they don’t always get used, yet “a lot of market research shows that people don’t carry them” so there’s a ton of waste in that.
“Our mission was: How do we get an easy, portable, carriable product? It should be as easy to carry as glucose tabs and have just as durable packaging,” says Oringer, who should well know, since he was involved in creating the original Dex4 products back in the ‘90s.
“Back then, we were competing with candy, cola and orange juice for treating lows – which are not carriable. We knew you need to be prepared and have something to carry with you.”
Finally, they hope this easy rescue device will offset the fear that many people have of starting insulin. “I hope Afrezza will help get more Type 2’s on insulin sooner, so they can have the best possible results. Meanwhile, every insulin company is talking about hypos more now because the newer products cause fewer lows,” Oringer added.
Ubiquitous as the EpiPen
Part of the mission is to vastly increase the awareness of hypoglycemia among the general public, Oringer says.
“We have the Heimlich maneuver, CPR, and the EpiPen – which you now find in restaurants and at stadiums — so people are well-informed about those sorts of rescue. On the other hand, hypoglycemia is like the Rodney Dangerfield of diabetes. It’s there but no one talks about it. The public is completely uninformed.”
They hope to form an awareness-raising coalition including the big national advocacy orgs, the insulin companies themselves, and grassroots efforts like patient advocate Zoe Heinemann’s Hypo Awareness campaign. They praise her work especially in training police officers and emergency workers to better recognize and treat hypoglycemia.
We weren’t able to verify this stat, but Oringer and Piché tell us there are about 150,000 emergency workers in the U.S. who aren’t authorized to give glucagon in many jurisdictions because it’s an injection; all they can do is transport the patient to ER. “But yet through lobbying and training, the EpiPen can be given. We have a lot of work to do… and it’ll be easier with no needles involved,” Oringer says.
Yup, nasal glucagon could solve a huge problem all around. We are rooting for Locemia!
Under the direction of Dr. Roy Beck at the Jaeb Center in Tampa, FL, clinical studies with type 1 patients continue at eight different research sites. The company is delighted with its Phase 3 results and hopes to have more exciting news through the big annual meetings of ADA in June and AADE in August.
While the product is still being tweaked, “our success will be measured by the ability to expand the communication and education around hypoglycemia,” Oringer says.
**UPDATE** On Oct. 9, 2015, Lilly announced that it had acquired the worldwide rights to sell and distribute this intranasal glucagon being developed by Locemia Solutions and currently in Phase III clinical trials. See the news release here.