U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome

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Postmedia has not reviewed the content. by GlobeNewswire U.S. FDA Accepts Teva's New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette SyndromeAuthor of the article:Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designationNDA acceptance is supported by positive Phase 3 data, which were published in JAMA Neurology, and Phase 2b dataIf 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 years1THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountPARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 19, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today 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.3Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try again“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.5The 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).6Across the Phase 2b, Phase 2b OLE and Phase 3 clinical trials, no clinically meaningful changes were observed across the following areas with ecopipam use:4,5,6,7Body weight and Body Mass Index (BMI) Z-ScoreVitals and laboratory measures, including metabolic parametersElectrocardiogram (ECG) measurementsDrug-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 comorbiditiesThis advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.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.4,5,6Teva 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.About Tourette SyndromeTourette 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.2About Ecopipam and Its Clinical ProgramEcopipam 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.4 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.5 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.6 While this Phase 3 trial included adult participants, the accepted NDA and resulting indication sought by Teva are exclusively for pediatric patients.About TevaTeva 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 StatementsThis 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 and additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the 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,” “Other Information” 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.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.CDC | Tourette Syndrome | Data and Statistics on Tourette Syndrome, 2024; Mayo Clinic | Tourette Syndrome – Diagnosis and treatment, 2025.Tomczak KK et al. High Rates of Discontinuation of D2 Receptor Antagonists as Treatment of Tourette Syndrome in Children: A Retrospective Database Analysis American Academy of Neurology (AAN) Annual Meeting Poster, 2025.Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette Syndrome: A Randomized Trial. Pediatrics. 2023;151(2):e2022059574. doi:10.1542/peds.2022-059574Gilbert 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.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.2026.1431Data on file.Teva Investor Relations InquiriesTevaIR@tevapharm.comNotice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.