A novel low-sodium oxybate product, TRN-257, is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy, as well as idiopathic hypersomnia in adults, according to an announcement by Tris Pharma. The application utilizes the FDA’s 505(b)(2) pathway and includes pharmacokinetic and safety data.
FDA Review Timeline and Application Details for TRN-257
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 20, 2026, for the TRN-257 New Drug Application. According to Tris Pharma, the submission incorporates findings from safety studies and pharmacokinetic evaluations, alongside data derived from previously marketed oxybate treatments. Additionally, human factors studies submitted in the application demonstrated that patients were able to use the product as intended based on proposed labeling.
“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, pointing to the company’s proprietary delivery platforms.
Mechanism and Formulation Design of the Once-Nightly Treatment
Sodium oxybate is the sodium salt of gamma-hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter GABA. Therapeutic effects of the compound are believed to operate through GABAB actions at noradrenergic, dopaminergic, and thalamocortical neurons.
TRN-257 employs proprietary technology utilizing the RaftWorks and LiquiXR platforms developed by Tris Pharma scientists. This formulation is designed to allow once-nightly administration while significantly reducing sodium content compared to other oxybate therapies, delivering 80 milligrams of sodium for a 9-gram dose.
“The unique formulation design developed by Tris scientists… achieves drug delivery capabilities that are expected to redefine the patient experience,” Mehta stated regarding the potential impact on long-term health management.
Context within the Sleep Disorder Treatment Market
The review of TRN-257 arrives alongside ongoing developments in low-sodium therapeutic options for sleep disorders. Jazz Pharmaceuticals markets Xywav, another low-sodium oxybate approved for narcolepsy and idiopathic hypersomnia, which recently highlighted new dosing flexibility data at the SLEEP 2026 conference to demonstrate expanded real-world use.
While established treatments such as Xywav focus on flexible dosing regimens within the U.S. market, the potential approval of TRN-257 by its June 2026 target date would introduce an alternative once-nightly option engineered specifically to lower sodium intake for adults managing chronic sleep and hypersomnolence conditions.
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