US FDA Accepts Teva’s Application for a New Tourette Syndrome Treatment

Ecopipam receives priority review

The US Food and Drug Administration (FDA) has accepted Teva Pharmaceuticals’ application for ecopipam, a new treatment being developed for children and adolescents with Tourette syndrome.

The FDA has granted the medicine Priority Review, with a decision expected in the first quarter of 2027.

What is Tourette syndrome?

Tourette syndrome is a neurological condition that usually develops during childhood or adolescence. It causes involuntary movements and sounds known as tics.

In the US, the condition affects around 100,000 children and adolescents. Current treatments do not work equally well for everyone, and some patients may experience side effects that make long-term treatment difficult.

How could ecopipam help?

Ecopipam works on the brain’s dopamine system and is designed to reduce the severity of tics.

Clinical studies have shown positive results. In a Phase 3 study, patients treated with ecopipam had a 53% lower risk of symptoms returning compared with those receiving placebo.

The treatment was generally well tolerated. The most common side effects included headache, insomnia, fatigue, sleepiness, anxiety, nausea and restlessness.

What’s next?

If approved by the FDA, ecopipam could become the first new treatment option for Tourette syndrome in more than 10 years.

Teva plans to continue its clinical development programme and work toward providing a new treatment option for children and adolescents living with Tourette syndrome and their families.