Teva Pharmaceuticals TEVA announced that the FDA has accepted the new drug application ("NDA") seeking approval for its investigational drug, ecopipam (EBS-101). Ecopipam is a first-in-class selective dopamine D1 receptor antagonist being developed for the treatment of pediatric patients with Tourette syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected in late first quarter of 2027. If approved, ecopipam could become the first new Tourette syndrome therapy in more than 10 years and the first novel mechanism of action in more than 50 years.
Year to date, TEVA's shares have gained 20% compared with the industry’s 8.6% growth.
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A priority review designation means the FDA’s goal is to take action on an application within six months compared with 10 months under standard review.
Ecopipam was added to Teva’s pipeline in June with the acquisition of Emalex Biosciences for $700 million in upfront cash. The acquisition strengthened Teva’s late-stage neuroscience pipeline and supports its Pivot to Growth strategy.
Tourette syndrome is a chronic neurodevelopmental disorder that causes involuntary motor and vocal tics, typically beginning in childhood. The condition affects approximately 100,000 children and adolescents in the United States, with symptoms often disrupting daily life. Many patients discontinue current treatments due to limited efficacy or treatment-related side effects, highlighting the need for better options.
Teva’s Strong D1AMOND Data Support Ecopipam NDA
The NDA filing for ecopipam in pediatric Tourette syndrome was backed by positive data from phase IIb and phase III D1AMOND studies. In the phase IIb study, ecopipam significantly reduced tic severity compared with placebo, achieving a statistically significant improvement in the Yale Global Tic Severity Scale-Total Tic Score at week 12, with efficacy maintained in the long-term open-label extension. The phase III randomized-withdrawal study further demonstrated durability, with pediatric responders receiving ecopipam showing a 53% lower risk of relapse over 12 weeks.
The drug was generally well-tolerated in clinical studies, with commonly reported side effects.
Teva’s Broader Neuroscience Pipeline
Beyond ecopipam, Teva is advancing several other neuroscience assets, including olanzapine long-acting injectable ("LAI") and emrusolmin (TEV-286). Olanzapine LAI is under regulatory review in the United States and European Union, with Teva targeting a U.S. launch in the fourth quarter of 2026, subject to approval. Emrusolmin is being evaluated in a phase II study for multiple system atrophy. The candidate is being developed in collaboration with MODAG.
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