TSA, Psyadon Pharmaceuticals partner for ecopipam clinical trial in Tourette Syndrome

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.

Marked by involuntary movements and sounds called "tics," TS is an inherited, neurobiological disorder frequently misunderstood by the public and often misdiagnosed medically.

Various off-label drugs are prescribed by medical professionals for TS, but of these, only two — pimozide and haloperidol — are approved by the FDA for the treatment of TS. These medications often provide only mild to moderate benefit and have poorly tolerated side effects that limit their use.

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 (18 to 65 years of age) with TS. The study is being conducted at four sites across the U.S. by leading experts in the field of TS and is expected to last for several months. Further information on the clinical trial can be found at www.clinicaltrials.gov.

This study is designed, and will be conducted with safety being a top priority. It will be jointly monitored by TSA and Psyadon, and an independent Drug Safety Monitoring Board will be responsible for an impartial evaluation of the study.

"Neither ecopipam nor any other drug with a similar mechanism has been tested in TS. Therefore, the results of this study will be immensely valuable. The TSA-Psyadon collaboration sets the precedent for our future partnerships with the pharmaceutical industry," said Dr. Kevin McNaught, Vice President for TSA Medical and Scientific Programs.