FDA Grants Orphan Drug Designation to Once-Nightly Oxybate for Idiopathic Hypersomnia
The FDA has granted Orphan Drug Designation to Tris Pharma’s TRN-257, an investigational once-nightly, low-sodium oxybate therapy for the treatment of idiopathic hypersomnia. The designation recognizes the potential for this formulation to reduce nocturnal treatment burdens while offering a lower-sodium alternative for patients requiring long-term care.