By Staff Reports
(DGIwire)–Tourette syndrome (TS) is a neurological disorder, usually first noticed in childhood, characterized by repetitive, involuntary movements and vocalizations called tics. The National Institute of Neurological Disorders and Stroke (NINDS) estimates that 200,000 Americans have the most severe form of TS and as many as one in 100 exhibit milder and less complex symptoms. For anyone who suspects that a family member might have TS, here are three questions to ask:
“We have nearly completed our Phase IIa clinical study at Yale University to assess the potential for our investigatory compound THX-TS01, which combines THC and PEA,” says Ascher Shmulewitz, MD, PhD, Chairman of the Board of Directors of Therapix. “The goal is to create a therapy that offers benefits currently lacking in available treatments.”
The company is pursuing the development of THX-TS01 by utilizing a 505(b)(2) regulatory strategy based on prior US Food and Drug Administration (FDA) approval of dronabinol; the company is also seeking Orphan Drug Designation from the FDA. Top-line results from the Phase IIa study of THX-TS01 at Yale University are expected in early 2018; Therapix will proceed accordingly from there.
“Our goal is to one day provide a therapeutic treatment that may give TS patients and their doctors an optimal treatment paradigm for the debilitating, unmet medical need,” Dr. Shmulewitz adds.