You are at the airport about to depart on a much-needed vacation. Picture yourself, with a favorite traveling companion, sitting in the concourse. Only a pane of glass and a few feet separate you and your aircraft. A perky airline employee makes the typical preboarding announcement. One short flight and you’ll be somewhere refreshing.
You wait for five minutes, then ten. Oddly enough the same chipper employee does not continue the process of boarding the plane. You look over and see him talking on that official-looking phone. The look on his face is not enthusiastic anymore. A few moments later the employee hangs up the phone, and quickly disappears through a set of mysterious airport doors. You continue waiting. Your anticipated departure time comes and goes; and yet; there is no news. You have no idea what this apparent delay means or why it is occurring.
All you know is that the “powers that be” are delaying an event you have anticipated – an event that is very important to you. You know there are thousands of good reasons why a flight might be delayed. If it's a safety delay, you want them to take the time they need. In any case, you just want some news. You just want to understand.
People with Parkinson’s are waiting. However, their hurdle is not a petty flight delay. They are waiting for one particular drug, Rasagiline, which may slow the progression of their disease. In July 2004, the FDA made its “preboarding announcement” when it issued an approvable letter to Teva Neuroscience, Inc. and Eisai Inc., the product’s co-promoters. However, since that time, the PD community has heard little news about the delay.
Is the hold up due to an FDA concern? Could the companies that plan to market Rasagiline have issues? Did a statistician in a cubicle make a mistake? Certainly, it would be a mistake to assume that any of these scenarios is true. Bringing a new drug to patients is a very complex process. In the mean time European and Israeli regulators approved Rasagiline early last year. It is marketed under the brand name Azilect®.
Rasagiline is an MAO-B inhibitor. Its main function is to slow down the breakdown of dopamine. This helps to keep the supply of dopamine in the brain longer. However, the PD community is hopeful that Rasagiline will be able to slow down the progression of Parkinson’s disease.
Numerous studies measured the benefits and safety of Rasagiline. Rasagiline indeed reduces off time, and improved symptoms. However, it is much harder to measure how well a medication “slows down” a disease. With PD, the disease progresses slowly over years. Naturally, it takes years to measure the “slowing down”.
Science starts in laboratories. Rasagiline was able to delay PD’s progress in laboratory animals. However, the question about its ability to do the same in humans still remains. The most well known study to
start to measure Rasagiline’s ability to slow PD is nicknamed TEMPO.
TEMPO study
404 people with Parkinson’s participated in this study for 52 weeks. Researchers found that PD progressed slower in patients that took Rasagiline during the study, compared to patients who did not. The weakness of the study is that it only lasted 52 weeks. Scientists would like to see that this slowing down affect continued to exist over a few years. For now, this is more of a hint of Rasagiline's ability to stall PD.
So, for now, scientists measure and Americans with PD wait. They do not know why - - but, they wait.
Other Rasagiline links:
Click here to read an overview of Rasagiline.
A
Press Release from Teva Neuroscience on the TEMPO study.
Click here for a more detailed article on the TEMPO study.
The United Kingdom
Rasagiline New Medicines Profile
The
European Public Assessment Report from the the European Medicines Agency. This is a for readers that want a fair amount of in-depth reading. Click on the blue diamond to select the section of the report you want, in the language that you want.
If you have insight or an opinion about this Rasagiline story (or any other), please email Matt at
mnilsen@myparkinsonsinfo.com. We read all email, and very frequently use it to create stories.
