 |
 |
In a response for more information made by the Parkinson's Disease Foundation, the President of Kyowa Pharmaceuticals sent this letter to the Parkinson's Community. see http://www.pdf.org/news/news.cfm?type=1&selectedItem=436 I've heard of a few people who were in the trial and thought the drug was beneficial. It is disconcerting to read in news articles that this " new drug may help people with Parkinson's disease combat the tics, spasms and tremors they experience when their main medications wear off, a new study suggests. " And then in the same article learn that the development has been suspended in North America. It sounds like the sponsor and the FDA couldn't come to ageement on approving the drug. Why not? THere is more information about KW-6002 (under "Istradefylline" and its development in the Parkinson Pipeline Project database ( http://www.pdpipeline.org/ ) I'd also like to hear from list members who had participated in any of these trials www.pdpipeline.org -- Archie R <[log in to unmask]> wrote: Was anyone on this list in the clinical trial? On Tue, Jun 3, 2008 at 4:45 PM, [log in to unmask] <[log in to unmask]> wrote: > Drug May Cut Tremors Associated With Parkinson'sBut relief not on way, > since FDA has said evidence of drug's effectiveness lacking. > MONDAY, June 2 (HealthDay News) -- A new drug may help people with > Parkinson's disease combat the tics, spasms and tremors they experience when > their main medications wear off, a new study suggests. > Istradfeylline works by helping nerve and brain signals bypass the damaged > dopamine system in the brain that leads to Parkinson's. A study of 395 > Parkinson's patients on levodopa, a popular Parkinson's drug, found those > using istradefylline experienced 24 percent less "off" time, defined as when > the physical symptoms appear after levodopa wears off. A group of those > studied who took a placebo showed a 10 percent decrease in "off" time. > "These results suggest that istradefylline is effective as an add-on > therapy to other drugs that treat symptoms of Parkinson's disease. More > importantly, this medication seems to improve 'off' time in a population in > which more than 90 percent of patients are already being treated with two or > more drugs," study author Dr. Mark Stacy, of Duke University Medical Center > in Durham, N.C., said in a prepared statement. > The findings, published in the June 3 issue of Neurology, may not mean > relief is coming soon for Parkinson's sufferers, at least in the United > States. In March, the U.S. Food and Drug Administration refused to approve > the drug, calling evidence of its effectiveness insufficient. The drug's > manufacturer, Kyowa Pharmaceuticals Inc., has suspended development of > istradefylline in North America. > The study was supported by Kyowa Pharmaceutical. > Istradefylline is a novel drug approach to Parkinson's. The disease is > usually treated with medications that work on dopamine, but their > effectiveness wears off after time. Istradefylline appears to connect with > receptors other than dopamine to open communication with the brain. > "Istradefylline and other agents in the same class that work in a different > area of the brain are an important step forward when treating patients who > experience this wearing off phenomenon and side effects related to > dopaminergic drugs," Stacy said. > http://healthfinder.gov/news/newsstory.asp?Docid=615943 > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: mailto: > [log in to unmask] > In the body of the message put: signoff parkinsn > ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn