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  1. #1
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    Default Is Abgard As Effective as Gartrogard?

    Basically what the title says. Is the Abgard, much cheaper, the same as the Gastro/Ulcergard in treating ulcers, then switch to Abprazole for maintenance?
    Lost in the Land of the Know It Alls



  2. #2
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    Default

    My vet thinks its exactly the same. I'm treating with Abgard and I'll be repeating the scoping in the end of the month, so I can post then.



  3. #3
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    Default

    What is Abgard....do you have a link or website info



  4. #4
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    Default

    Abgard is the proper name for the "blue pop rocks" from www.omeprazoledirect.com

    A head to head trial will NEVER be performed, as Gastrogard is due to come off patent within a year or two and will then become generically available, at which point the billion-dollar cash cow will dry up considerably. (although don't count on the price coming down quickly)

    It would also behoove NOBODY other than Abler Rx to perform such a study, and that is not the business that generic drug manufacturers are in.

    So it remains up to the individual to decide for themselves if they "trust" that the generic product is up to the same standard as the brand name.

    I use the pop rocks and have a fairly significant comfort level that they do what they are supposed to do. But I don't have any "proof" in terms of large series of animals with documented ulcers treated with one or the other with repeat scoping to show improvement. That is what it would take to be sure, and again those studies will never be done.
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  5. #5
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    Default

    The pop rocks are not Abgard, they're Abprazole and actually work in a different way then Abgard and Gastrogard.



  6. #6
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    Default

    Actually the "blue pop rocks" are Abler (company) but the drug is still omeprazole I am not sure what Abgard is, but omeprazole is omeprazole which is the ingredient in GG that heals the ulcers.

    What mostly matters for this is to make it past the stomach acid so the drug must be coated in a way that saves it from being destroyed in the stomach and be absorbed later.



  7. #7
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    Default

    Abgard is Abler's paste omeprazole. I don't know how it is protected from digestion. We know the pop rocks have enteric coating but assume they buffer the paste somehow.



  8. #8
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    Default

    My apologies for mixing up Abgard and Abprazole! Mea maxima culpa . . . I was not aware their (newish?) paste had a different name.
    Click here before you buy.



  9. #9
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    Nov. 15, 2009
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    Default

    Just wanted to add - a natural item used often in racehorses for preventing stomach ulcers is Papaya Juice. Horses love the taste of it and it seems to work well. Much cheaper than Gastrogard. We typically would give 40-60mL of Papaya 2X/day. (bigger the horse, the closer to 60mL we gave) I never met a horse that wouldn't happily slurp Papaya juice out of the syringe. :-) Just thought I'd mention it!



  10. #10
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    Default

    Quote Originally Posted by SCMSL View Post
    The pop rocks are not Abgard, they're Abprazole and actually work in a different way then Abgard and Gastrogard.
    They work the same (theoretically) - its just the vehicle for getting the omeprazole safely to where it needs to be is different.

    Paste - one would assume they have a buffering ingredient, so the stomach pH is changed so that the omeprazole is not "killed" in the stomach. Then, the omeprazole safely makes it through, then starts its job by limiting acid production.

    Granules - they have a coating so the stomach pH doesn't need to be changed to get them to where they need to go. The coating protects the drug, it gets through the acidy stomach, then goes to work.

    Either method: eventually, once the omeprazole starts working and the acid stops being produced, you could techically administer unbuffered, uncoated omeprazole and it would continue to work...because there's no acid in there to "kill" it.
    "If you think nobody cares about you, try missing a couple payments..."



  11. #11
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    Default

    Quote Originally Posted by deltawave View Post
    A head to head trial will NEVER be performed, as Gastrogard is due to come off patent within a year or two and will then become generically available, at which point the billion-dollar cash cow will dry up considerably. (although don't count on the price coming down quickly)

    It would also behoove NOBODY other than Abler Rx to perform such a study, and that is not the business that generic drug manufacturers are in.

    So it remains up to the individual to decide for themselves if they "trust" that the generic product is up to the same standard as the brand name.

    I use the pop rocks and have a fairly significant comfort level that they do what they are supposed to do. But I don't have any "proof" in terms of large series of animals with documented ulcers treated with one or the other with repeat scoping to show improvement. That is what it would take to be sure, and again those studies will never be done.
    This statement is completely incorrect. In order for a generic company to bring another omeprazole paste version to market, they WILL need to perform bioequivalence studies to show the two formulations perform identically. This would be filed as an ANDA to the original NDA.

    If a generic company wants to bring a new dosage form to market (ie, coated granules), they would need to do so under a 505b2 filing. This kind of filing is more costly in and of itself (filing fees to FDA), and would require a more complete data package to submit than an ANDA (ie, more studies completed). A company could also potentially challenge Merial under a Paragraph IV filing, but that has high financial risks.
    ~Living the life I imagined~



  12. #12
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    Default

    By head to head I meant a large, randomized, blinded clinical trial. But perhaps you can help me understand--when "bioequivalence" needs to be demonstrated, are there large enough numbers of subjects to actually demonstrate noninferiority in terms of ulcer healing, or is some other metric used like plasma drug levels?
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  13. #13
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    Oct. 24, 2003
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    Default

    I guess what I have been trying to figure out is the suggested TREATMENT to cure ulcers is Gastro/Ulcergard paste for a month and then I see a lot of folks use the pop rocks for continued prevention. Or, I also see that you can give three packets (for my size horse) of the pop rocks for TREATMENT & then reduce as decided for prevention. I am trying to decide to try Aber's Abgard paste first for treatment & then go with the pop rocks for prevention, or just go with the pop rocks. Obviously, I would like to go the most effective route, but also as cost efficient as I can.

    I have not had my horse scoped to confirm ulcers. The only signs he seems to be exhibiting has been increased spookiness that has accelerated over the past year & maybe some sensitivity under his belly when I bathe & scrape with the sweat scraper.

    This is a horse that was dead head quiet on the trails and now is very reactive, mainly to deer crashing in the bushes. He used to just sort of startle in place & snort. Now he has become hyper vigilant and will do the wheel sideways & spin. I had myself convinced it has been because our deer population in NO. VA has so gotten out of control those Crackhead Bambis travel in gangs & burst as a herd out of nowhere. My lovely, quiet trail rides hacking on the buckle are a thing of the past.

    He's better hacking out with company, but still spooks more than he used to. He's a fabulous eater, almost too much of an easy keeper so he gets a small amount of low NSC feed, a couple of small flakes of alfalfa when stalling inside during the summer & turn out on pasture in the evening currently. He doesn't seem like a prime ulcer candidate, but I'm willing to try the ulcer treatment to see if it makes a difference.

    I might be grasping at straws, but I'm trying to get inside his head or maybe his stomach to get the quiet guy I used to have back. He used to love to go out on the trails by himself. He still will, but spends a lot of the time being bug eyed.

    Suggestions appreciated!
    Lost in the Land of the Know It Alls



  14. #14
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    Default

    Quote Originally Posted by deltawave View Post
    By head to head I meant a large, randomized, blinded clinical trial. But perhaps you can help me understand--when "bioequivalence" needs to be demonstrated, are there large enough numbers of subjects to actually demonstrate noninferiority in terms of ulcer healing, or is some other metric used like plasma drug levels?
    Drugs being filed under an ANDA (ie, generic) do not need to go through the various levels of clinical trials and toxicity studies in animals, healthy subjects, and patients the way innovator NCE (new chemical entities) do, as per provisions under the Hatch-Waxman Act. They DO need to demonstrate bioequivalence to the innovator.

    BE is determined through measuring plasma concentrations in evaluating the PK (pharmacokinetics) of the two products in healthy subjects, with a 90% correlation to the innovator being considered "equivalent". But, as with much of FDA guidance, there is a lot of room for interpretation. A company can try to submit analytical and dissolution data only if there is an IVIVC established (in-vivo in-vitro correlation, which basically means that the drug can be expected to perform in an analytical dissolution test method as it would in an actual live body. This is only appropriate for certain types (BCS 1 drugs- highly soluble, highly bioavailable- and only certain formulations of drugs (oral suspensions, IR tablets).

    Because omeprazole is drug that requires an MR (modified release), not only does FDA request BE studies, they would want both "fasted" (subject takes med on empty stomach) and "fed" (patient takes med on full stomach) to assess the impact of what is called the "food effect".

    I do not have a good understanding of HOW MANY patients would be required for BE studies, especially in horses/ veterinary medicine. I've seen numbers as low as 25-30 subjects in human trials, but I can imagine this would range up in to hundreds or thousands for certain types of drugs/ indications.

    I am quite certain a generic company has the BE studies and filing ready to go for the day the Merial products come off patent. The formulation of the product is fairly simple. It's the regulations that are lots of red tape to get through.

    (sorry to derail your thread OP- either product should work as well as the other; it depends whether the granules or paste fit into your care program more easily. I would give the higher dose for treatment, and the lower dose for prevention in stressful situations.)
    ~Living the life I imagined~



  15. #15
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    Default

    I am quite certain a generic company has the BE studies and filing ready to go for the day the Merial products come off patent.
    NO doubt. I was sort of angling my line of thought towards the Abler product and its status as a semi-outsider since it is sort of dodging US FDA oversight by being manufactured overseas and imported "privately", if you will. Wondering if that company has any intention of going through the process you describe when the time comes. (yes, a rhetorical question to which I don't think anyone here can reply) But thank you for clarifying my points and educating me some more.
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  16. #16
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    Default

    No problem. I'm actually at a conference in New York right now, and over a break I chatted with a colleague of mine who specializes in generics. He said basically the same thing that I thought re: what is required for BE studies - "it depends" (on drug type, classification, indication, etc)

    I got curious myself about the nuances for veterinary medicine, so I just looked up FDA's Guidance for Industry for Abbreviated New Animal Drug Applications (ie, generic animal drugs). It also doesn't make mention of the number of subjects required, but does talk about preferred methods of studies (blood plasma) vs PK or clinical endpoints, and the need for positive, negative, and test controls.

    It would be interesting to know if Abler plans to file with FDA- perhaps they are even already one of the generics lined up with their ANADA ready to go once the patent runs out. It would be even more highly interesting to know if the "COTH effect" is causing enough of a ripple in Merial's sales of UG/GG such that Merial would be motivated enough to try to get FDA to do something about the, ahem, private importations, in advance of the patent expiration.
    ~Living the life I imagined~



  17. #17
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    For the cost that a run on Abler would cost in legal and administrative fees, they could just drop the price of the danged drug 20% and come out even.
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  18. #18
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    Quote Originally Posted by KentuckyTBs View Post
    Just wanted to add - a natural item used often in racehorses for preventing stomach ulcers is Papaya Juice. Horses love the taste of it and it seems to work well. Much cheaper than Gastrogard. We typically would give 40-60mL of Papaya 2X/day. (bigger the horse, the closer to 60mL we gave) I never met a horse that wouldn't happily slurp Papaya juice out of the syringe. :-) Just thought I'd mention it!
    I think if you look closely it is actually papaya puree, not juice. I know omeprazole is derived from papaya but not sure if that is the only source.



  19. #19
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    I know omeprazole is derived from papaya
    Can you point me in the direction of where this information originally comes from? I have never been able to find anything that confirms this.
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  20. #20
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    Nope. Just repeating what I have been told so take it for whatever it is worth.



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