FUDiabetes

Xeris Announces Positive Outcomes from a Global Phase 3 Clinical Trial

Press release from Xeris:

Apparently one of the goals of the study was providing additional for European marketing authorization. Do the European regulation agencies require more evidence than the FDA? “Findings will support application for European marketing authorization and augment body of data supporting efficacy and utility of its ready-to-use, stable liquid glucagon”

This article has a chart comparing Xeris’s Gvoke pen and syringe with a regular glucagon kit:
https://seekingalpha.com/article/4269514-xeris-gvoke-pdufa-gets-delayed-creates-buying-opportunity
There’s also a figure with the instructions for the auto-injector administration procedure. I noticed that in contrast with the Epipen, the more conical tip of the pen is not the needle end and that the safety cap is on the needle end instead of the other. I wonder if this might cause confusion among people familiar with the Epipen.

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That is a nice improvement over the current glucagon kits, looking forward to that being available and reducing the footprint of the current solution. I think the really cool part of that will be pumps able to deliver both insulin and glucagon. How cool would that be.

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I am excited for this. I do wonder why it comes in a pouch rather than a hard case. I also wonder why it says to remove clothing. The EpiPen can be used through clothing except for perhaps really thick clothing. I also dislike having to wait till the window turns red; that is not accessible to people with visual impairments, or even just in low-light situations. I wonder why they couldn’t just say hold it in for 10 seconds (which is what EpiPen used to instruct, though I think they’ve reduced that to 3 seconds now).

When this comes out I do plan to get it. I do have concerns that I’d then be carrying both an EpiPen and HypoPen (if that’s what they end up calling it). I’m already concerned that people wouldn’t know when to use which device, and I agree that the instructions being quite different is also a concern. Mind you, the EpiPen is just the most well-known of several epinephrine auto-injectors, each of which have their own varying instructions. So I think the most important thing would be to train yourself and close friends and family and coworkers on whichever device(s) you are carrying, and repeat the training often enough that they remember the differences.

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Just have them deliver both in case of passing out, that way you have all bases covered. Nothing like a little epinephrine to get the party started. /s

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This is exactly what I’d do, not just if I was unconscious, but even if someone just couldn’t remember which symptoms matched which condition matched which auto-injector. In fact, I may put a note in my emergency kit for others that says as much. Considering my allergist told me to administer both, I think they actually enhance the effects of the other.

Related to the glucagon auto-injector: I was talking to a friend yesterday who mentioned that nasal glucagon is expected to come out this summer. I think that may end up being more popular than an auto-injector. It’ll be interesting to see what happens. I think the nasal spray is expected to come to Canada, so if that’s the case, I’ll get some of that instead of the auto-injector.

Isn’t it dangerous to get a dose of epinephrine if you’re not having an allergic reaction?

Nope. Not unless you accidentally inject the EpiPen into your thumb or something like that (in which case it can cut off blood supply, apparently). I’ve heard of many adults and children accidentally injecting themselves without consequences. Your body produces epinephrine all the time. The only case in which it might be dangerous is in people with certain heart conditions.

The reason people need to go to the hospital after they use epinephrine for an allergic reaction is that they’re experiencing a potentially life-threatening reaction and need to be monitored in case additional treatment is necessary. It’s not because of the epinephrine itself.

Caveat: I am not a doctor. But this is what I’ve read and heard over the years.

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Yeah, that would be cool. Though I lately read an endo claiming that the amounts of glucagon deliverd by artificial pancreases are higher than the normal production by a pancreas and that we don’t know the long term effects of subcutaneous glucagon injection. On the other hand I see no reason why it would be harmful.

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