Posted by Michael Wonder on 11 Dec 2025
Tris Pharma announces FDA acceptance of NDA for once nightly, low sodium oxybate product for narcolepsy and idiopathic hypersomnia
9 December 2025 - Tris Pharma today announced that the US FDA has accepted the company’s new drug application for TRN-257 for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy and the treatment of idiopathic hypersomnia in adults.
The FDA has set a PDUFA goal date of 20 June 2026.
