- FDA grants Orphan Drug Designation (ODD) to Tris Pharma’s TRN-257 for the treatment of idiopathic hypersomnia, based on the plausible hypothesis that TRN-257 may be clinically superior to currently available oxybate products
- As a once-nightly oxybate, TRN-257 is designed to make a major contribution to patient care by eliminating the need for awakening in the middle of the night to take the second dose often required by patients with IH
- TRN-257, if approved, will be the lowest sodium (80mg sodium for 9g dose) once-nightly oxybate product, reducing sodium burden while allowing uninterrupted nighttime sleep
MONMOUTH JUNCTION, N.J., June 10, 2026 (GLOBE NEWSWIRE) -- 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 granted Orphan Drug Designation to TRN-257 (oxybate for extended-release oral suspension) for the treatment of idiopathic hypersomnia (IH). Specifically, the designation was granted based on the plausible hypothesis that TRN-257 may be clinically superior to oxybate products already available for the same indication, because TRN-257 may provide a major contribution to patient care due to its once-nightly dosing for most patients with IH, a chronic sleep disorder that requires potentially lifelong treatment.
“Idiopathic hypersomnia is a serious and often underrecognized disorder of sleep and wakefulness that can substantially impair daily functioning, quality of life, and long-term wellbeing,” said Maurice M. Ohayon, MD, DSc, PhD, Professor and Director, Stanford Sleep Epidemiology Research Center at Stanford University. “The FDA’s orphan drug designation for TRN-257 highlights the continuing need to advance differentiated therapeutic options for this patient population. A once-nightly, low-sodium oxybate formulation may be clinically meaningful if it can reduce nocturnal treatment burden while maintaining efficacy and safety.”
“The granting of orphan drug designation for TRN-257 recognizes the potential for a major contribution to patient care and marks an important milestone for the treatment of patients with idiopathic hypersomnia,” said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma. “This milestone is a testament to the innovation of Tris scientists using our unique RaftWorks™ and LiquiXR® platforms. TRN-257 is designed to provide clinically meaningful benefits to patients by combining once-nightly dosing with the lowest sodium content among oxybate products in development, which may be an important consideration for patients who are sensitive to or who need to manage their sodium intake.”
The orphan drug designation is intended to support the development of therapies for rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation may provide certain development and commercial incentives, including eligibility for a seven-year period of market exclusivity in the United States following product approval, if the product is approved for the designated indication.
TRN-257 is Tris’ investigational, once-nightly, low-sodium oxybate product candidate being developed for the treatment of IH and for the treatment of cataplexy or excessive daytime sleepiness (EDS) with narcolepsy.
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
Narcolepsy and idiopathic hypersomnia are chronic, debilitating neurological disorders of sleep and wakefulness. Narcolepsy affects an estimated 37.7 out of 100,000 individuals in the U.S. (less than 200,000 Americans) and is characterized by excessive daytime sleepiness (EDS) and cataplexy. IH is a separate, rare disorder characterized by chronic, disabling EDS and substantial functional burden that potentially requires lifelong treatment.
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 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.
Company Contact
Cheryl Patnick
Tris Pharma, Inc.
cpatnick@trispharma.com
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Madelin Hawtin
LifeSci Communications
MHawtin@lifescicomms.com
