FDA Accepts NDA for TRN-257 for Treatment of Narcolepsy and Idiopathic Hypersomnia

Tris Pharma today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TRN-257—a controlled-release, low-sodium oxybate product—for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy and the treatment of idiopathic hypersomnia in adults.¹

When compared with other oxybate treatment options, TRN-257 is the lowest sodium (80 mg sodium for 9 g dose), once-nightly treatment currently in development for adults with narcolepsy and idiopathic hypersomnia. Low-sodium treatment options are crucial in this patient population as they experience profound fatigue, impaired quality of life, and an increased risk of serious cardiovascular comorbidities. Furthermore, existing high-sodium oxybates can potentially exacerbate hypertension and other cardiovascular risks.

“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, a 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.”

The 505(b)(2) NDA submission is supported by data from multiple pharmacokinetic and safety studies and involves Model Informed Drug Development-based approaches to demonstrate efficacy and safety of TRN-257. The submission also includes the FDA’s previous safety and efficacy findings from currently-marketed oxybate products as well as a comprehensive Human Factors Engineering and Usability Engineering (HFE/UE) study report. The HFE/UE validation study showed the ease of use of TRN-257 with representative patients generally able to perform critical tasks and use TRN-257 as intended when following the proposed labeling.

TRN-257 was developed by combining Tris’ 2 proprietary technologies: RaftWorks™ and LiquiXR®. These technologies allow for a low sodium, once-nightly delivery, thus eliminating the need for patients to wake for a second dose.² Specifically, RaftWorks enables sustained, controlled release and absorption of drugs that have a narrow window of absorption; and slowly and continuously releases drug from the raft, which enables absorption in the upper gastrointestinal tract. Meanwhile, LiquiXR is a particle-based technology that combines principles of ionic chemistry and science of controlled release to enable delivery in oral liquid and solid dosage forms; and enables sustained, controlled release for oral medicines while maintaining benefits of immediate release.

“The FDA’s acceptance of our NDA for TRN-257 reflects Tris Pharma's commitment to solving complex therapeutic challenges,” said Ketan Mehta, the founder and chief executive officer of Tris Pharma. “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 FDA has set a Prescription Drug User Fee Act goal date of June 20, 2026.

References

1. Tris Pharma announces FDA acceptance of NDA for once-nightly, low-sodium oxybate product for narcolepsy and idiopathic hypersomnia. News release. December 9, 2025. Accessed December 9, 2025. https://www.businesswire.com/news/home/20251209571909/en/Tris-Pharma-Announces-FDA-Acceptance-of-NDA-for-Once-Nightly-Low-Sodium-Oxybate-Product-for-Narcolepsy-and-Idiopathic-Hypersomnia

2. Expanding the possibilities with patient-inspired technology. Tris Pharma. Accessed December 9, 2025. https://staging.trispharma.com/our-focus/technology-platform/