Seaside Therapeutics Announces End of Arbaclofen (STX209) Extension Study

Seaside TherapeuticsLate 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 STX209 (arbaclofen) in Subjects with Fragile X Syndrome] is being terminated. The closure of the study is due to resource limitations at Seaside Therapeutics, Inc., and is not related to any known safety issue in patients taking the drug.”

Everyone who is participating in this study will be contacted by your individual clinic. Please remember there are many people for each site to contact and this could take some time. Every participant will be given instructions on the process of tapering your child off of the drug which could take anywhere from 1 to 4 weeks, depending on the current dose. You will then have an opportunity to work with your child’s doctor to determine the next, best step in your child’s treatment.

It is our understanding that Seaside will continue to analyze the data from the trials and work for FDA approval if these trials show benefit that is sufficient for approval.

All of us at the NFXF know that for many of you the news that your son or daughter will need to soon stop taking arbaclofen is very upsetting. We have heard your descriptions of the improvements you have observed in your child during the trial, or the extension, and we know how worried you are about the change.

Over the past few months our executive director, Robert Miller, has had the opportunity to meet with the Fragile X teams at other pharmaceutical companies and he says they all appear to be fully committed to their own drug development and clinical trials.

So please, work closely with your child’s doctor and remain hopeful and optimistic that new and better treatments are still forthcoming.

We will continue to keep you informed of the current drug trial available to families on our website. You can see a currently listing of current ongoing clinical trials at clinicaltrials.fragilex.org.