Neuropsychiatry in the News: Wearable Technology for Parkinson Disease, Ecopipam for Tourette Syndrome

Today, August 19, the FDA has moved forward 2 different potential treatments for neuropsychiatric conditions. Read the news here.

Wearable Technology Receives FDA Clearance for Parkinson Disease Monitoring

The US Food and Drug Administration (FDA) has given 510(k) clearance to the Empatica Health Monitoring Platform for Parkinson disease.¹

The Empatica Health Monitoring Platform uses clinical-grade wearables, a patient app, cloud technology, and a clinician portal to monitor symptoms over time. The tech provides validated measures of bradykinesia, dyskinesia, tremor, sleep, medication compliance, and other aspects of Parkinson disease management. Notably, these algorithms have been evaluated in over 70 peer-reviewed publications and used across more than 150 hospitals and clinical sites worldwide.

"Wearable monitoring enhances our understanding of how Parkinson's symptoms change daily and respond to treatment," said Ritesh Ramdhani, MD, an associate professor of neurology and the director of the Deep Brain Stimulation Program and Parkinson's and Movement Disorders Division at Northwell Health. "Bringing objective, real-world data into clinical care can assist clinicians in making more informed, personalized decisions and better support people living with Parkinson's."

The new 510(k) clearance expands the company's clinical-grade monitoring platform into Parkinson disease, following its established work in epilepsy and sleep. According to research, the platform enables continuous symptom monitoring and provides objective data to support more personalized care. The technology has been widely used by pharmaceutical companies, hospitals, and universities in Parkinson disease research, including studies of disease progression, treatment response, and digital measures in clinical trials.

"This clearance marks an important step forward for Parkinson's care," said Matteo Lai, the CEO and cofounder of Empatica. "We are bringing objective monitoring into a platform designed for great user experience and scale. This can help people better understand their symptoms, provide clinicians with data to support more personalized care, and give researchers deeper insight into disease progression and treatment response."

FDA Accepts NDA and Grants Priority Review for Ecopipam for Pediatric Patients With Tourette Syndrome

Teva Pharmaceuticals today announced that the FDA has accepted the New Drug Application (NDA) for ecopipam, with a targeted action date set for late in the first quarter of 2027. Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation, and an investigational therapy for the treatment of pediatric patients with Tourette syndrome.²

The NDA acceptance for ecopipam is supported by positive phase 2b and phase 3 data. In the phase 2b study, participants 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) compared with placebo at week 12 (P = 0.01).³ Durability of efficacy was shown in participants who later enrolled in a phase 2b open-label extension (OLE) study.⁴

“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, MD, PhD, the executive vice president of 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 phase 3 randomized withdrawal study further demonstrated maintenance of efficacy with ecopipam. For the primary endpoint, pediatric ecopipam responders compared with placebo had a 53% decreased risk of relapse over 12 weeks (P=0.008).⁵

Across the phase 2b, phase 2b OLE, and phase 3 clinical trials, no clinically meaningful changes body weight and Body Mass Index (BMI) Z-Score; vitals and laboratory measures; electrocardiogram measurements; drug-induced movement disorders; or measures of psychiatric comorbidities were associated with ecopipam use.

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.^3-5

References

1. Empatica receives FDA clearance for Parkinson's monitoring. News release. August 19, 2026. Accessed August 19, 2026. https://www.prnewswire.com/news-releases/empatica-receives-fda-clearance-for-parkinsons-monitoring-302854529.html

2. 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. News release. August 19, 2026. Accessed August 19, 2026. https://www.tevapharm.com/news-and-media/latest-news/u.s.-fda-accepts-tevas-new-drug-application-nda-and-grants-priority-review-for-ecopipam-a-first-in-cl

3. Gilbert DL, Dubow JS, Cunniff TM, et al. Ecopipam for Tourette syndrome: a randomized trial. Pediatrics. 2023;151(2):e2022059574.

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.

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.