10 February 2020 - Oliceridine is a new chemical entity intended for the management of moderate-to-severe acute pain.
Trevena today announced that it has resubmitted its new drug application to the U.S. FDA for IV oliceridine, the Company’s lead investigational product for the management of moderate-to-severe acute pain. The Company anticipates a six-month review period by FDA.
The application for oliceridine was resubmitted based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on their complete response letter.