This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.~Protocol 209AS208, A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects with Autism Spectrum Disorders.~Protocol 22007, An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder.~This open-label extension will provide data on the following:~Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)~Provide supporting pharmacokinetic analyses~Assess long term efficacy on social behaviors in subjects with ASD.
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.