Teva Presents New Efficacy and Safety Data with Ecopipam, an Investigational Treatment for Pediatric Patients with Tourette Syndrome

The 18-month interim extension analysis reported sustained tic suppression with no new safety signals observed.

Rhea-AI Summary

Teva (TEVA) announced new efficacy and safety analyses of ecopipam, its investigational treatment for pediatric patients with Tourette syndrome.

A pooled post hoc analysis, conducted after the trials, found clinically meaningful tic improvement in 69.8% of 292 patients within eight weeks. An interim analysis of an ongoing open-label extension, in which treatment was known, reported a 45.6% mean reduction in tic severity scores through 18 months, with no new safety signals. That study included 118 participants with median exposure of 14.9 months. A separate post hoc analysis of 216 participants found that common co-occurring psychiatric conditions did not negatively affect efficacy or safety during the 12-week open-label period. Ecopipam's pediatric application is under FDA Priority Review.

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0 major · 3 points

How the balance works

Positive

• Moderate pointFDA Priority Review and Orphan Drug designation were granted for ecopipam in pediatric Tourette syndrome.
• Minor point69.8% of 292 patients experienced clinically meaningful tic improvement within eight weeks in a pooled post hoc analysis.
• Minor point45.6% mean tic severity score reduction was reported through 18 months in the interim extension analysis.
• Minor pointNo new safety signals were observed in the interim 18-month extension analysis.
• Minor pointCo-occurring psychiatric conditions did not negatively affect efficacy or safety in a 216-participant, 12-week post hoc analysis.

Negative

• Minor pointEarly-response and psychiatric subgroup findings came from post hoc analyses; the long-term extension analysis was interim and open-label.
• Minor pointSomnolence and headache were the most commonly reported adverse events in the pooled early-treatment analysis.
• Minor pointExtension adverse events most commonly included nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia.

Key Figures

Clinically meaningful tic improvement: 69.8% Pooled analysis population: 292 patients Mean tic severity score reduction: 45.6% +4 more

Clinically meaningful tic improvement

69.8%

Within the first 8 weeks of treatment

Pooled analysis population

292 patients

Phase 2b and Phase 3 trials

Mean tic severity score reduction

45.6%

Interim 18-month analysis

Open-label extension study population

118 participants

Received at least one dose of ecopipam

Median treatment exposure

14.9 months

Open-label extension study

Psychiatric-condition subgroup analysis

216 participants

Phase 3 trial; 129 with and 87 without common co-occurring conditions

Clinically meaningful improvement threshold

Score ≥25%

YGTSS-TTS improvement definition in the pooled analysis

Key Terms

post hoc analysis, open-label extension, placebo-controlled, randomized withdrawal trial, +2 more

6 terms

post hoc analysis technical

"In a pooled post hoc analysis of 292 patients across Phase 2b and Phase 3 trials"

Post hoc analysis is an exploratory look at data carried out after a study or trial is finished to search for patterns or effects that were not specified beforehand. Because it’s done after seeing the results, findings can arise by chance and are less reliable than preplanned tests; investors should treat post hoc claims as hypothesis-generating signals that may need confirmatory studies or regulatory review before they meaningfully affect a company’s value.

open-label extension medical

"long-term efficacy and safety from an interim analysis of an ongoing open-label extension"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

placebo-controlled medical

"a 12-week randomized, double-blind, placebo-controlled trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

randomized withdrawal trial medical

"a double-blind, placebo-controlled, randomized withdrawal trial"

A randomized withdrawal trial is a clinical study in which everyone first receives an active treatment, then those who respond are randomly assigned either to keep taking the treatment or to stop or switch to a placebo, and outcomes are compared to see if benefits persist. Think of it like letting everyone drive a new car model, then taking the keys from half to see whether problems or declines return. Investors care because it tests how durable a drug’s effects and safety are over time, which influences regulatory decisions, prescribing, and commercial value.

orphan drug designation regulatory

"with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

priority review regulatory

"granted Priority Review by the FDA"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

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• Based on a post hoc analysis, a majority of participants (~70%) experienced clinically meaningful tic reduction within 8 weeks of starting ecopipam
• An interim 18-month analysis of an ongoing open-label extension study demonstrated a mean reduction in tic severity scores (45.6%) with no new safety signals observed
• Additional analyses found that common concurrent psychiatric conditions did not negatively impact ecopipam’s efficacy or safety, adding to the growing body of evidence supporting ecopipam’s application currently under FDA Priority Review
  
  

PARSIPPANY, N.J., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data for ecopipam, a first-in-class investigational selective D1 (dopamine) receptor antagonist for the treatment of pediatric patients with Tourette syndrome. Presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Seoul, South Korea (October 4–8, 2026), the data include a post hoc analysis of safety and efficacy during the initial 8 weeks of treatment with ecopipam, long-term efficacy and safety from an interim analysis of an ongoing open-label extension (OLE) study, post hoc subgroup analyses and preclinical receptor selectivity findings.

“Tourette syndrome is a complex neurodevelopmental disorder that presents significant daily challenges for children and their families,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer of Teva. “These promising new data for ecopipam reinforce our confidence in its potential in pediatric Tourette syndrome care. If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first with a novel mechanism of action in more than 50 years.”

Key Findings from Studies Include:

• Tic Severity Reduction Observed Within Two Months of Treatment: In a pooled post hoc analysis of 292 patients across Phase 2b and Phase 3 trials, a clinically meaningful improvement in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS) (score ≥25%) was observed in 69.8% of participants within the first eight weeks of treatment with ecopipam. The most commonly reported adverse events (AEs) were somnolence and headache, and the most commonly reported cross-trial AEs were most often observed within the first eight weeks of ecopipam exposure.
  
  
• Clinically Meaningful Reduction in Tic Severity Sustained >1 year: An interim analysis of an ongoing 36-month OLE study included patients who completed the phase 3 study and the phase 2b OLE study receiving ecopipam titrated over 3-4 weeks then maintained at a target dose for up to 36 months. The study evaluated 118 children, adolescents and adults with Tourette syndrome who received at least one dose of ecopipam (median treatment exposure of 14.9 months). Ecopipam maintained clinically meaningful tic suppression through 18 months according to the YGTSS-TTS. The most commonly reported AEs were nasopharyngitis, upper respiratory tract infection, anxiety, diarrhea, influenza, pyrexia and insomnia.
  
  
• Co-Occurring Psychiatric Conditions Did Not Impact Efficacy or Safety of Ecopipam: A post hoc analysis evaluated 216 participants (aged ≥6 years) from the Phase 3 trial, comparing outcomes between those with (n=129) and without (n=87) common co-occurring psychiatric conditions, including ADHD, OCD, anxiety and depression. During the 12-week open-label period, the presence of co-occurring conditions did not negatively impact reductions in tic severity, with mean YGTSS-TTS score reductions consistent across participants with ≥1 co-occurring conditions and those without. Overall safety and tolerability profiles were similarly consistent between both groups.
  
  

“Many children with Tourette syndrome do not receive treatment, and among those who do, treatment is often discontinued within a year because symptoms remain inadequately controlled or side effects become difficult to tolerate,” said Donald L. Gilbert, M.D., M.S., Pediatric Movement Disorders and Tourette Syndrome Specialist, Division of Neurology, Cincinnati Children’s Hospital Medical Center. “Children living with Tourette syndrome urgently need treatment options that work rapidly, remain effective over time and have a demonstrated tolerability profile. These findings are encouraging because they suggest that, if approved, ecopipam may offer patients and families a meaningful new option.”

About Tourette Syndrome
Tourette syndrome is a chronic neuro-developmental disorder characterized by involuntary motor and vocal tics beginning in childhood, often between 5 and 10 years of age.² For people living with Tourette syndrome, symptoms can be frequent, visible and disruptive, affecting everyday life.²

About Ecopipam and Its Clinical Program
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.

Ecopipam was granted Priority Review by the FDA with Orphan Drug designation for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.

The D1AMOND Phase 2b Trial was a 12-week randomized, double-blind, placebo-controlled trial that studied 153 pediatric participants across 68 sites in North America and Europe. The primary efficacy endpoint was the change in the YGTSS-TTS, i.e., sum of the motor and vocal tic scores, from baseline to end of therapy.³ The associated Phase 2b open-label extension enrolled 121 pediatric subjects from the Phase 2b trial and followed them for up to 12 months’ duration to evaluate the long-term safety and tolerability of ecopipam.⁴ The subsequent D1AMOND Phase 3 Trial was a double-blind, placebo-controlled, randomized withdrawal trial enrolling a total of 216 pediatric and adult participants into an open-label stabilization period and randomizing 104 participants (90 pediatric, 14 adult) across 77 sites in North America and Europe. The objective of this study was to evaluate the maintenance of efficacy of ecopipam in pediatric and adult responders utilizing the YGTSS-TTS change from randomization or increased Tourette-specific care to determine relapse.⁵ While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva’s future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “developing,” “target,” “may,” “expand,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to successfully develop, obtain regulatory approval for and commercialize ecopipam; our ability to successfully compete in the marketplace including our ability to develop and commercialize ecopipam for the treatment of pediatric patients with Tourette syndrome; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and to profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

References:

1. U.S. Food and Drug Administration (FDA) Approval Records: Haloperidol (1969), Pimozide (1984), Aripiprazole (2014); Pringsheim, T., et al. (2019). The pharmacological management of tic disorders: an updated practice guideline. Neurology.
2. CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025.
3. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574
4. Gilbert DL, Kim DJB, Miller MM, et al. Safety and Effect of 12-Month Ecopipam Treatment in Pediatric Patients with Tourette Syndrome. Mov Disord Clin Pract. 2025;12(8):1157-1166. doi:10.1002/mdc3.70091.
5. Gilbert DL, Atkinson SD, Kim DJB, et al. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026;83(7):645–653. doi:10.1001/jamaneurol.2026.1431
   
   

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How quickly did Teva's ecopipam reduce tics in the new analysis?

Clinically meaningful tic improvement occurred in 69.8% of participants within eight weeks of starting ecopipam. The pooled post hoc analysis included 292 patients from Phase 2b and Phase 3 trials and measured improvement using the Yale Global Tic Severity Scale Total Tic Score, a measure of motor and vocal tics.

Is Teva seeking ecopipam approval for adults with Tourette syndrome?

The accepted new drug application and the indication Teva seeks are exclusively for pediatric patients. Although the Phase 3 trial included adults, its randomized population comprised 90 pediatric participants and 14 adults.

How long is Teva's ongoing ecopipam extension study planned to last?

The ongoing open-label extension evaluates ecopipam treatment for up to 36 months. It includes patients who completed the Phase 3 study or the Phase 2b open-label extension, with dosing increased over 3–4 weeks before maintenance at a target dose.