Tris Pharma Announces FDA Acceptance of NDA for Once-Nightly, Low-Sodium Oxybate Product for Narcolepsy and Idiopathic Hypersomnia

• As the lowest sodium (80mg sodium for 9g dose), once-nightly treatment currently in development, TRN-257 has the potential to be the new standard of care for adults with narcolepsy (cataplexy or excessive daytime sleepiness) and idiopathic hypersomnia
• TRN-257 was developed by combining Tris’ two proprietary technologies – RaftWorks™ and LiquiXR® – to attain low sodium, once-nightly delivery eliminating the need for patients to wake for a second dose
• Excess sodium may have an impact on long-term cardiovascular health. TRN-257 is designed to significantly reduce the daily sodium burden compared to existing higher-sodium therapies

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on developing innovative therapies for unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for TRN-257 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy and the treatment of idiopathic hypersomnia (IH) in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 20, 2026.

“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, Director, 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 FDA’s acceptance of our NDA for TRN-257 reflects Tris Pharma's commitment to solving complex therapeutic challenges,” said Ketan Mehta, 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 505(b)(2) NDA submission is supported by data from multiple pharmacokinetic (PK) and safety studies and involves Model Informed Drug Development (MIDD)-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.

Tris is actively exploring US and Global partnership opportunities for the commercialization of TRN-257.

About Tris' RaftWorks™ and LiquiXR® Technology

TRN-257 utilizes two of Tris’ proprietary, innovative technology platforms, RaftWorks™ and LiquiXR®, to achieve its differentiated, controlled-release profile and enable the once-nightly, low-sodium dosing regimen.

RaftWorks™

• Enables sustained, controlled release and absorption of drugs that have a narrow window of absorption
• Slowly and continuously releases drug from the raft, enabling absorption in the upper gastrointestinal (GI) tract
• Employs an inter-penetrating polymer network (IPN) to create an in situ floating “raft” that disintegrates with the use of pre-determined triggers

LiquiXR®

• Particle-based technology that combines principles of ionic chemistry and science of controlled release to enable delivery in oral liquid and solid dosage forms
• Enables sustained, controlled release for oral medicines while maintaining benefits of immediate release
• Over nine NDAs approved in the US in addition to products approved in 33 countries around the world

About Narcolepsy and Idiopathic Hypersomnia (IH)

Narcolepsy and idiopathic hypersomnia (IH) are chronic, debilitating neurological disorders of sleep and wakefulness. Narcolepsy affects an estimated 1 in 2,000 individuals in the U.S. (over 200,000 Americans) and is characterized by excessive daytime sleepiness (EDS) and cataplexy. IH is a separate, rare disorder estimated to affect tens of thousands of diagnosed adults in the U.S. and is characterized by chronic, disabling EDS. Patients with these conditions suffer from profound fatigue, impaired quality of life, and an increased risk of serious cardiovascular comorbidities. The need for low-sodium treatment options in this population is critical due to the potential for existing high-sodium oxybates to exacerbate hypertension and other cardiovascular risks.

About Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris markets a portfolio of best-in-class ADHD products and is developing a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.