Teva Drug Fails to Beat Placebo in Pediatric Tourette Patient Trials

Xconomy National — 

A Teva Pharmaceutical drug in testing as a treatment for tics in pediatric patients with moderate-to-severe Tourette syndrome has failed two late-stage trials.

Israel-based Teva (NYSE: TEVA) said Wednesday that the drug, deutetrabenazine, didn’t beat a placebo in reducing motor and phonic tics—the main goals of the Phase 2/3 and Phase 3 trials. Those signs of Tourette were measured according to a ratings scale used to measure the severity of such symptoms.

Tourette syndrome, which appears during childhood, is characterized by tics that persist for more than one year. Tics are unwanted movements or sounds, such as eye blinking or repeating words or phrases, that are difficult to control. Typically, symptoms peak around age 10, and most people individuals with the condition see their symptoms improve in late adolescence and into adulthood.

The condition is estimated to affect 1 to 10 in 1,000 children, and is more common in males than in females, according to the National Institutes of Health.

The Phase 2/3 Tourette study, ARTISTS 1, study enrolled 119 patients age 6 to 16, who were randomized to receive either deutetrabenazine or a placebo over 12 weeks. In the Phase 3 study, ARTISTS 2, 158 patients in the same age range were randomized to receive either a low dose of deutetrabenazine, a high dose of the drug, or a placebo over eight weeks.

Teva, which partnered with San Francisco-based Nuvelution Pharma on the Tourette studies, said the most commonly reported side effects in the trials were headache, sleepiness, and fatigue.

In 2017 Teva secured FDA approval for deutetrabenazine as a treatment for two conditions that involve involuntary movement: tardive dyskinesia, a side effect of long-term use of some psychiatric drugs, and uncontrolled movements, or chorea, in patients with Huntington’s disease. Both approvals were for adults with the conditions.