CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, announced publication of results from two Phase 1 pharmacokinetic (PK) studies of IV oliceridine, one in patients with end-stage renal disease and one in patients with hepatic impairment, in Clinical Pharmacology in Drug Development. The results demonstrate that no dose adjustments are needed in patients with renal impairment or in patients with mild / moderate hepatic impairment.
The publication, “The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine” with lead author Anne Nafziger, M.D., Department of Medicine at St. Peter’s Hospital, Albany, NY, is available online at https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.750.
“Due to the accumulation of active metabolites, conventional IV opioids often require dosage adjustments when administered to patients with renal or hepatic impairment. The results of these two studies demonstrate that there is no clinically relevant difference in oliceridine clearance in patients with renal or hepatic dysfunction,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. “These findings suggest that oliceridine may provide a new IV analgesic treatment option with clinical advantages for these at-risk patient populations.”
Study Summary and Key Findings:
- A Phase 1, multi-center, open-label study evaluated oliceridine PK, safety, and tolerability in 17 subjects with end-stage kidney disease. In these subjects with severe renal impairment, there was no clinically relevant change in oliceridine total clearance (>50% difference) or other PK parameters compared with healthy age- and sex-matched controls.
- A Phase 1, multi-center, open-label study evaluated oliceridine PK, safety, and tolerability in 34 subjects with mild, moderate, and severe hepatic impairment. In subjects with mild, moderate, and severe hepatic impairment, there were no clinically relevant differences in oliceridine total clearance compared with healthy subjects. Additional PK findings suggest that initial dose reduction in individuals with severe hepatic impairment should be considered, as they may require fewer doses of oliceridine compared to healthy individuals.
- The most commonly reported adverse events (AEs) were nausea, fatigue, and euphoria. All treatment-emergent AEs in both studies were of mild intensity.
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA 19087
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