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- NDA submission supported by positive Phase 3 data recently published in JAMA Neurology.
- Ecopipam is a first-in-class selective dopamine D1 receptor antagonist with a novel mechanism of action and has received FDA Orphan Drug and Fast Track designations
- Ecopipam could be the first FDA-approved treatment option for pediatric Tourette syndrome in more than a decade, if approved.
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TEL AVIV, Israel, June 18, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ecopipam, a first-in-class investigational therapy for the treatment of pediatric Tourette syndrome.
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“The NDA submission for ecopipam is a significant milestone for a potential first-in-class treatment option in pediatric Tourette syndrome,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “This reflects the momentum in our innovative pipeline through our recent acquisition of this important asset, and advances our Pivot to Growth strategy and commitment to bringing differentiated medicines for patients.”
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The NDA submission is supported by positive Phase 3 data recently published in JAMA Neurology, which showed that ecopipam significantly delayed time to relapse compared with placebo in pediatric patients with Tourette syndrome who had achieved a clinical response during the open-label treatment period. In the study, ecopipam demonstrated a statistically significant benefit on the primary efficacy endpoint in pediatric patients (p = 0.008) and was generally well tolerated, with the most common adverse events related to ecopipam therapy including somnolence, insomnia, anxiety, fatigue and headache.
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About Tourette Syndrome
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Tourette syndrome is a chronic neuro-developmental disorder character by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age. For people living with Tourette syndrome, symptoms can be frequent, visible, and disruptive, affecting everyday life. Despite the current treatment options available, many patients continue to experience inadequate treatment control or treatment-limiting side effects, underscoring the need for additional options.
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About ecopipam
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Ecopipam is a first-in-class investigational therapy designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.
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Ecopipam has received Orphan Drug and Fast Track designations from the FDA for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.
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Results from the Phase 3 study in Tourette syndrome were recently published in JAMA Neurology. The primary efficacy endpoint in the study was time to relapse (based on YGTSS-TTS scale) for pediatric patients who were stable and responding to ecopipam. The study showed statistical significance between ecopipam and placebo for the primary efficacy endpoint in pediatric patients (p = 0.008). Ecopipam was generally well-tolerated in the study and the most common adverse events related to ecopipam therapy were somnolence (n = 24 [11.1%]), anxiety (n = 21 [9.7%]), headache (n = 21 [9.7%]), insomnia (n = 19 [8.8%]), tic (n = 17 [7.9%]), and fatigue (n = 14 [6.5%]).
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