• Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation
• NDA acceptance is supported by positive Phase 3 data, which were published in JAMA Neurology, and Phase 2b data
• If approved, ecopipam would be the first new treatment option indicated for pediatric patients with Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years¹
  
  

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ecopipam, with a targeted action (PDUFA) date late in the first quarter of 2027. Ecopipam is a first-in-class investigational therapy for the treatment of pediatric patients with Tourette syndrome. This milestone advances Teva’s Pivot to Growth strategy by utilizing the company’s expertise in neuroscience to support patients, particularly in areas where there is high unmet need.

Tourette syndrome is a debilitating neuro-developmental condition impacting approximately 100,000 children and adolescents nationwide.² Only half of these patients are treated with prescription medication for this condition, and only 20-30 percent remain on therapy after one year. Despite the current treatment options available, many patients continue to experience inadequate control or treatment-limiting side effects.³ This patient experience underscores the urgent need for new prescription drug options and reinforces Teva’s commitment to expanding access to innovative neuroscience treatments for underserved patient populations.³

“Ecopipam’s NDA acceptance is an important milestone that advances Teva’s Pivot to Growth strategy and brings us closer to addressing the unmet needs of children and their families affected by Tourette syndrome,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years, offering patients and families a long-awaited new treatment option.”

The NDA acceptance for ecopipam is supported by positive Phase 2b and 3 data. In the Phase 2b study, patients receiving ecopipam experienced a reduction in tic severity, with statistically significant and clinically meaningful improvement in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) vs. placebo at Week 12 (P = 0.01).⁴ Durability of efficacy was shown in participants who subsequently enrolled in a Phase 2b open-label extension (OLE) study.⁵

The Phase 3 randomized withdrawal study, recently published in JAMA Neurology,⁶ further demonstrated maintenance of efficacy with ecopipam. For the primary endpoint, pediatric ecopipam responders compared to placebo had a 53% decreased risk of relapse over 12 weeks (p=0.008).⁶

Across the Phase 2b, Phase 2b OLE and Phase 3 clinical trials, no clinically meaningful changes were observed across the following areas with ecopipam use:^4,5,6,7

• Body weight and Body Mass Index (BMI) Z-Score
• Vitals and laboratory measures, including metabolic parameters
• Electrocardiogram (ECG) measurements
• Drug-induced movement disorders (DIMD) as measured by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS) or Extrapyramidal Symptom Rating Scale (ESRS)
• Measures of psychiatric comorbidities
  
  

Ecopipam was generally well-tolerated and the most common adverse events in pediatric patients with Tourette syndrome were headache, insomnia, fatigue, somnolence, tics, anxiety, nausea and restlessness.^4,5,6

Teva remains deeply committed to advancing this clinical program and, if approved, delivering a long-awaited new treatment option to pediatric patients with Tourette syndrome who have historically relied on treatment options primarily developed for other conditions.