FDA Accepts Ecopipam NDA for Tourette Syndrome
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Teva Pharmaceuticals has announced FDA acceptance and Priority Review of its New Drug Application for ecopipam, a targeted therapy for pediatric Tourette syndrome.
FDA news, the administration has accepted Teva Pharmaceuticals' new drug application (NDA) for ecopipam, a first-in-class selective dopamine D1 receptor antagonist under investigation for pediatric patients with Tourette syndrome (TS), and granted the submission priority review. The company noted that the agency set a target action date under the Prescription Drug User Fee Act (PDUFA) for late in the first quarter of 2027.
Eric Hughes, MD, PhD, executive vice president, global R&D and chief medical officer at Teva, told NeurologyLive® this, “We are encouraged by the FDA's acceptance of the ecopipam application and grant of Priority Review. Tourette syndrome is an area where innovation has been limited for far too long, with patients and clinicians often relying on treatments developed for other conditions,”
The NDA application is supported by data from the phase 2b and phase 3 D1AMOND clinical program. In the 12-week, randomized, double-blind, placebo-controlled phase 2b trial, 153 pediatric participants across 68 sites in North America and Europe were randomized to ecopipam or placebo. Findings showed that those receiving ecopipam had a statistically significant and clinically meaningful reduction in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) versus placebo at week 12 (P = .01). A subsequent open-label extension followed 121 pediatric participants for up to 12 months and reported sustained tic control.
“The Phase 2b and Phase 3 data supporting this application demonstrated meaningful and durable reductions in tic severity with a favorable tolerability profile, giving us confidence in ecopipam's potential as a differentiated treatment option,” Hughes added. “If approved, we believe ecopipam's novel D1 receptor mechanism could provide clinicians with an important new option to help children and adolescents better manage their symptoms and the impact those symptoms can have on daily life."
