MONMOUTH JUNCTION, N.J. — The U.S. Food and Drug Administration has accepted Tris Pharma’s New Drug Application for TRN-257, a once-nightly, low-sodium oxybate formulation intended for adults with narcolepsy with cataplexy or excessive daytime sleepiness, as well as adults with idiopathic hypersomnia. The agency set a Prescription Drug User Fee Act decision date of June 20, 2026.
TRN-257 contains significantly less sodium than currently available oxybate therapies and is designed to eliminate the need for patients to wake during the night for a second dose. Excess sodium intake has raised concerns about long-term cardiovascular effects among individuals who rely on existing high-sodium formulations.
“Currently, patients face a difficult trade-off with existing treatments that either burden them with high sodium levels, posing significant cardiovascular risks, or require disruptive twice-nightly dosing that interrupts sleep, that otherwise is intended to induce sleep,” said Maurice M. Ohayon, MD, DSc, PhD, Professor and Director of the Stanford Sleep Epidemiology Research Center at Stanford University. “As the first oxybate formulation to combine a convenient once-nightly regimen with the lowest sodium content, TRN-257 is uniquely designed to eliminate this compromise.”
Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma, said the FDA’s acceptance marks a key step for the investigational therapy. “The FDA’s acceptance of our NDA for TRN-257 reflects Tris Pharma’s commitment to solving complex therapeutic challenges,” he said. “The unique formulation design developed by Tris scientists — using our innovative RaftWorks and LiquiXR platforms — achieves drug delivery capabilities that are expected to redefine the patient experience, potentially offering a life-changing improvement in how they manage their condition and protect their long-term health.”
The application was submitted under the 505(b)(2) pathway and includes data from multiple pharmacokinetic and safety studies, along with Model Informed Drug Development analyses supporting the proposed dosing and safety profile. The submission also incorporates the FDA’s prior findings for approved oxybate products and results from a Human Factors and Usability Engineering study showing that representative patients were able to use the product and follow instructions as intended.
Tris Pharma said it is evaluating potential U.S. and international commercial partnerships for TRN-257.
