Wednesday, September 16, 2009

Generic Alternative to EpiPen and TwinJect? Not Exactly...

On Sept. 16, 2009, Adamis Pharmaceuticals Corporation announced that Walgreens will begin to offer its epinephrine pre-filled syringes (Epi PFS) as a generic alternative to epinephrine autoinjectors.

Certainly, it is wonderful to have a lower-cost alternative to EpiPen and TwinJect. (Tier 1 co-pay on Aetna and Cigna!) Many parents cough up $70 or more out of pocket for epinephrine autoinjectors that end up being thrown away. Now, don't get me wrong- I think it's much better to spend the money and throw it away than not spend it and be without life-saving medication if you should need it. But when you need one for home, one for school, one for grandma's house, etc... it adds up.

On top of that, I like to prescribe epinephrine for my immunotherapy patients, and they aren't thrilled about the co-pay either, especially when the prescription is only a precaution.

However, just because the medication inside the syringe is the same doesn't mean that device is equivalent to the branded drug. The beauty of epinephrine autoinjectors is just that- they auto-inject. You don't see the needle until it comes out of your leg, the risk of sticking yourself is lower, and the risk of accidentaly squirting your life-saving medication into the air is lower as well. Try as I might, I cannot find a photograph of Adamis's epinephrine "PFS". Their website doesn't describe the product/device, except to state that "While an extremely important piece of Adamis Labs’ product development strategy, Epi PFS serves as an introduction for the commercialization identity, and as a precursor, to its more long-term and higher potential revenue generating products."

Hmmm... Sorry, Adamis Pharma. Your public statements do very little to convince me that you really care about making a quality alternative to the existing market leader. It's possible that your product may have promise for adult patients who are unlikely to actually need it. However, until I can get my hands on your device and feel confident that it is both easy and safe for my patients and parents to use, my prescriptions will continue to be marked, "Dispense As Written".

Antibacterial Treatment Does Little to Reduce Staph Colonization, but Reduces Eczema Severity Nonetheless

I have a special interest in the treatment of severe eczema, and for years have been recommending to my patients treatments designed to reduce the burden of the bacteria known as staphylococcus aureus. Staph aureus, as it is commonly known, colonizes the skin and nose of up to 90% of patients with atopic dermatitis, or eczema. This not only can lead to infections in inflamed skin, but can also contribute to worsening of eczema when patients develop an allergy to the toxins produced by the bacteria.

The mainstays of antibacterial therapy for control of staph aureus colonization are: oral antibiotics, nasal antibiotics, and dilute bleach baths. The traditional thinking has been that implementing these measures would reduce the bacterial burden, thereby improving the condition of the skin.

Now, a fascinating study in the September issue of Pediatrics has turned the traditional wisdom on its head. Sure enough, patients treated with the anti-staph cocktail therapy had better outcomes than those treated with oral antibiotics alone, but there was no decrease in the levels of staph aureus colonization (80% before treatment, 82% after)!

So, the question is: why does the antibacterial regimen work if the bacteria are still there? The only explanation I can come up with is that perhaps the anti-staph treatments decreased the production of superantigen toxins which increase staph's infective ability and predispose patients to increased allergy in the skin. I'd be interested to see the results of a study examining the effects of bleach baths and intranasal antibiotics on staph superantigen production...
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