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The Parkinsonís Disease Foundation Counsels Caution in Interpreting Recent News Announcements about the Potential of Azilectģ to Slow the Progression of Parkinsonís Disease

(New York, NY)

PDF Urges that Conclusions About the Drug’s Effectiveness in Slowing PD Be Deferred Until Peer-Reviewed Results Have Been Published

The Parkinson’s Disease Foundation (PDF) is advising that the Parkinson’s community withhold judgment as to the potential disease modifying effect of Azilect®, an anti-PD medication manufactured by Teva Pharmaceuticals that is already approved and on the market for symptomatic relief in Parkinson’s, until the complete data from a large-scale recent study have been properly studied, peer reviewed and published in a reputable journal.

This PDF statement was prompted by an announcement earlier this week that the data from ADAGIO, a Phase III trial studying the drug’s ability to delay disease progression, had been presented for the first time to a scientific conference. The presentation was made in Madrid, Spain, at the 12th Congress of European Federation of Neurological Societies (EFNS), by one of the trial's principal investigators, Olivier Rascol, M.D., Ph.D., of the University Hospital Toulouse, France. At this time, the Parkinson’s Disease Foundation (PDF) has the following statement to share with the community. The statement has been approved by Dr. Christopher Goetz, Chief of Movement Disorders at Rush University in Chicago:

“This week’s report that results from ADAGIO have been presented at a scientific meeting is noteworthy in that it confirms completion of a very large and well-designed study of the potential modifying effects of clinical outcome in PD patients taking an anti-Parkinson’s medication. It is also interesting to note that the investigators reported that the group of patients receiving daily doses of 1 mg of Azilect from the onset of the study were less impaired at the end of the study than those who started the drug later during the study. The investigators presenting the data reported that the group receiving the chronic 1 mg dose of rasagiline (Azilect) met all three of the “primary end points” that were determined at the outset of the study to be the key outcomes of interest."

"It is also important to note that the data – though promising and provocative -- have not yet been made available widely in the scientific community, and even more importantly, they have not yet been exposed to the process of scientific peer review that is crucial to validating the results of scientific research. Until such time as the findings are published in a refereed scientific journal – which we hope will be no more than a few months from now – we are unable to say whether or not early treatment with Azilect has long term benefits in modifying the course of Parkinson’s disease-related disabilities. After critical review of the data and scholarly interpretation of the results, clinicians will be in a better position to determine if prescribing patterns and advice to patients will change. In the meantime, people with Parkinson’s who are interested in this matter, or who are concerned about their own treatment regimen, should consult individually with their physicians.”

This new announcement, along with an earlier one in June, have attracted considerable attention around the Parkinson’s community because to date, no medication has been proven to slow the course of Parkinson’s disease. All of the treatments currently available, including Azilect itself, have been approved for their capacity to ease symptoms, not to alter the underlying course of the disease. PDF will continue to keep its community, and the general public, apprised of relevant developments as they occur.

Robin Anthony Elliott, Executive Director

Source Date: Sep 04 2008