Trevena expects to resubmit NDA for oliceridine in 1Q20
The company said, "Completed multi-dose QT study for oliceridine. No accumulation of effect was observed on the QT interval. A small, transient effect, consistent with that observed in the single-dose QT study, began dissipating after 12 hours and was absent at the end of the 24-hour study period despite repeated dosing of oliceridine. Oliceridine was well tolerated, with 59 subjects receiving the 27 mg maximum daily dose. There were no serious adverse events. In addition to this data, the Company previously announced that it has completed the work to address the other items requested by FDA in their complete response letter for oliceridine. The Company expects to resubmit the NDA for oliceridine in the first quarter of 2020."