The official result of the Seaside trials was that STX209 did not do what its makers thought it would. The present structure of FDA trials requires that the proponents of a new drug predict what it will do and then conduct trials to determine whether the drug delivers the predicted results. If it does not, that particular trial is deemed a failure and cannot be relied upon to make the case for formal approval of the drug.
Video clip from local news station covering a family who participated in a study that later ended and they want to get their hands on the drug that they called a miracle drug.
(c) Photo: Laura Gilmore For more than 10 years the NFXF has been participating in the life-sized chess game that is the federal budget. Even before the decision was made to bring the »
Note: Just before I wrote this article, a group of parents that Margaret Mead could have easily been describing when she penned her most famous quote ("Never doubt that a small group of committed people »
When a lab experiment is being done for the first time it often has to be done six or more times before everything is finally correct and it finally works reproducibly. That’s distressing and frustrating, but this is actually more the rule than the exception. For a clinical trial the stakes are so much higher. It's not just distressing and frustrating for the researchers, but it also causes real disruption and agony in the lives of real people who are a part of these trials. So when we don't "get it right" the first time everyone suffers.
Photo by Daniel Acker for the New York Times On the front page of the Business section of the June 7 New York Times was an article regarding Seaside Therapeutics' ending of the »
Yesterday we received the following messages from Paul Wang, Vice President, Clinical & Medical Affairs at Seaside Therapeutics, Inc. Dear all - I wanted to let you know about a letter that we just posted »
To our Fragile X family: Many of you by now have heard the news that Seaside Therapeutics has decided to end their extension of the trial medication known as Arbaclofen (STX209). The NFXF Board of »
Late yesterday afternoon the NFXF, along with all of the study locations, was contacted by Seaside Therapeutics and informed that the “Study 209FX303 [An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of »
