Manila Times Business
Tris Pharma Announces FDA Grant of Orphan Drug Designation for TRN-257 (Oxybate for Extended-Release Oral Suspension) a Once-Nightly, Low-Sodium Oxybate Product for Idiopathic Hypersomnia
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 productsAs 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
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Source: manilatimes.net
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