Clinical Pharmacology Study With AZILECT(R) (Rasagiline Tablets) Demonstrated It Does Not Increase Tyramine Sensitivity

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Study Indicated Rasagiline Selectivity for Inhibiting MAO-B at Maximum Approved Dose


KANSAS CITY, Mo., June 9 /PRNewswire/ -- Teva Neuroscience, Inc. today presented results from a clinical pharmacology study in which AZILECT(R) (rasagiline tablets) did not increase the risk of tyramine sensitivity at the maximum approved dose of 1 mg. The presentation was made during the 13th International Congress of Parkinson's Disease and Movement Disorders in Paris, France. This study assessed the potential risk of hypertensive crisis due to the interaction between high doses of oral tyramine and therapeutic doses of rasagiline, which is indicated both as monotherapy in patients with early Parkinson's disease (PD) and as adjunctive treatment in patients receiving levodopa. The study supported the selectivity of rasagiline for inhibition of MAO-B at currently approved doses.

I really wish we could start getting data from studies that weren't funded by the same entity that makes the product in question. My doctor informed me that I should start takin Azilect immediately because of the results of the "ADAGIO"-I think it was called - Study, that showed, sort of, that patients who took Azilect over a period of some months (I think less than 24 months for sure) showed "less progression" than those who took a placebo. SO the big victory for Teva was that their product could be identified as the first to have been proven to delay the progress of the disease.

After he prescribed this drug, and said "You can read about the side effects if you want," I did just that, plus getting a little familiar with the study. I pointed out to my doc that the patients in the study had very little in common with me, having been recently diagnosed, on very few other PD meds, and obviously showing some notable progression. WHereas in my case, after 18 years after diagnosis, rapid progression has not been my biggest issue really. I also pointed out that the study acknowledged somewhere down at the bottom, that no other product has been tested with quite this format, inferring that it could well turn out that other products on the market could have the same effect, if studied within the particular parameters of the design of the ADAGIO study. (Nonetheless, Azilect recently got their patent status extended until 2017, I think. Teva stock immediately went up from like less than a dollar to over $40 in one afternoon, I think.)

ANyway, long story short, I told my doctor that given all this information, I didn't think it warranted me risking the side effects for this rather vague promise of benefit in my particular case. He immediately agreed, once I put it that way.

I'm not saying it wouldn't be very helpful for some people, and I hope it is. I'm just saying I wish we could learn about these products in ways that weren't heavy with prejudicial inferences, inevitable when the stockholders are funding the study.

Our whole system of evidentiary medicine has to change the way it does business. It is not scientific the way it is.

I wondered about this on the board, before azilect was even FDA approved. At that time, their literature stated that there was not the same tyramine problem as other mao inhibitors. Then, when approved, they changed their tune. To placate the FDA?