The national Tourette Syndrome Association (TSA) and Psyadon Pharmaceuticals Inc. are pleased to announce their collaboration on a clinical trial to determine the potential efficacy of a novel drug, ecopipam, for managing the symptoms of the neurological disorder Tourette Syndrome (TS).
"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, President of the NY-based not-for-profit organization.
The TSA will also assist with subject recruitment for the clinical trial of ecopipam, the rights to which are owned by Psyadon.
The FDA granted ecopipam an orphan-drug designation for the treatment of TS in September 2010. Richard Chipkin, President and CEO of Psyadon, stated, "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.
Psyadon and TSA anticipate the data from this clinical trial will be released by mid-2012.
For more information on orphan drugs and rare diseases check out the World Orphan Drug Congress USA.