“This is the first time in our 39-year history that TSA has collaborated with the pharmaceutical industry and helped to fund a clinical drug trial for the potential treatment of TS. It marks the beginning of a new phase in our efforts to facilitate the development of effective and safe medications that are urgently needed for people with TS,” said Judit Ungar, TSA President.
The TSA will also assist with recruitment for the clinical trial.
The FDA granted ecopipam an orphan-drug designation for the treatment of TS in September 2010. Richard Chipkin, President and CEO of Psyadon, said: “We are honored to be selected as the first company the TSA has collaborated with on a clinical drug study. Experiments in animals suggest that ecopipam, which belongs to a class of agents referred to as dopamine D1 antagonists, interacts with nerve cells and systems in the brain that are thought to contribute to the development of tics and other symptoms in TS. Based on these studies, there is a good rationale and a logical basis for examining this drug’s efficacy in reducing tic severity in individuals with TS.”
The clinical trial, which has already begun, is a Phase 2a, open-label, non-randomized trial to examine the ability of ecopipam to both reduce tic severity and also to determine its safety in individuals with TS who are 18 to 65 years old. The study, which is being conducted at four sites across the U.S. by leading experts in TS, is expected to last for several months. More information is available here.
Psyadon and TSA anticipate the data from this clinical trial will be released by mid-2012.