Study on bioequivalency of EpiPen and AuviQ

[maeve]

First, the study was funded by Mylan and one of the authors consults for Mylan.


The study noted that peak epinephrine concentrations happened 10 minutes after administration with the EpiPen and 30 minutes after administration with AuviQ.


http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3629870/

[twinturbo]

I'll go through the numbers and methods of the study later but I'm reading 10 for EpiPen and 20 for Auvi-Q, not 30.

based on median Tmax parameters, peak epinephrine concentrations for EpiPen occurred 10 minutes after dosing (0.170 hours, range 0.07–1.00) while peak concentrations for Auvi-Q occurred 20 minutes after dosing (0.330 hours, range 0.08–1.00)

Also noting that from the other link there's a blurb in there that Auvi-Q and EpiPen do have bioequivalence which I'm 110% sure maeve already knows since she posted both and there's no way she didn't find both articles at the same time. This is more directed at people carrying Auvi-Q to not freak out because Mylan funded one study.

The randomized, crossover study included 71 healthy adults. In three sequences over three treatment periods, nurses administered 0.3 mg doses of epineph- rine using Auvi-Q and EpiPen. Blood samples were obtained for pharmacokinetic measurements, and adverse events were assessed.

The peak concentration of and total exposure to epi- nephrine were comparable between the two devices. Both peak plasma concentration and area under the concentration-time curve supported the bioequivalence of epinephrine delivered via Auvi-Q and EpiPen. Treatment-emergent adverse events were almost all mild, and always resolved spontaneously. There was a 13% rate of injection-site pain with Auvi-Q versus 24% with EpiPen. Rates of injection-site bleeding were 5% and 10%, respectively.

The study demonstrates the bioequivalence of 0.3 mg doses of epinephrine administered with the new Auvi-Q devices compared to EpiPen. Safety and tolerability are similar with the 2 devices; Auvi-Q may be associated with less pain and bleeding.

[maeve]

I'll go through the numbers and methods of the study later but I'm reading 10 for EpiPen and 20 for Auvi-Q, not 30.

based on median Tmax parameters, peak epinephrine concentrations for EpiPen occurred 10 minutes after dosing (0.170 hours, range 0.07–1.00) while peak concentrations for Auvi-Q occurred 20 minutes after dosing (0.330 hours, range 0.08–1.00)

You're right.  My eye clearly focused on the 30 in .330. 

[maeve]

http://www.jaci-inpractice.org/article/S2213-2198(13)00125-6/abstract

[CMdeux]

Thing is, for FDA approval, Sanofi already had to demonstrate bioeq. 

If anything, Mylan ought to be investing in some actually needed improvements to design and function (longer needles, more compact design) rather than beating and beating on AuviQ. 

[twinturbo]

The way I understand Mylan's marketing spin on this is that it does not license its technology to allow for generic versions therefore it is legitimately able to claim there is no injector that is equivalent because in allowing no generics it is factually true if only because of its singularity of manufacture.

However, any injector making it past FDA's tests are all good to go for patient use. It's like the car seat model. All car seats and boosters must pass the same tests, meet the same minimal requirements. The manufacturers may have different models wih additional proprietary technologies that *may* confer additional safety but as these additional features are technologies that are not subjected to objective tests and measurements to meet minimum safety standards there is no claim to a safest seat: they all pass the same tests in order to make it to the shelves.

[twinturbo]

How many of us have seen EMS or ER docs or allergists using an autoinjector? None, in my experience. I've only seen med professionals use vial and syringe. I'm not sure how the peak could be that different given that the technology is in the delivery mechanism not a difference in the substance. Although I'm sure the needle length and force of injection would have some measurable difference as would site of injection. At any rate, the tech is to reduce human error, increase ease of portability, and protect the integrity of the substance and its delivery mechanism.