CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) announced the Company’s partner in China has enrolled the first patient in a Phase 3 trial for OLINVYK (oliceridine) injection, a novel IV analgesic approved in the U.S. by the Food and Drug Administration (FDA) for acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
“We are committed to delivering OLINVYK to patients and healthcare providers in need of alternative acute pain treatment options, both through our ongoing launch in the U.S. as well as our global partnerships,” said Carrie Bourdow, President and CEO of Trevena.
“I am pleased that Nhwa has reached this important clinical development milestone, and we look forward to supporting their efforts to secure regulatory approval of OLINVYK in China.”
The company states this is a randomized, double-blind, active-controlled study that will enroll approximately 160 patients following abdominal surgery. The study includes an OLINVYK arm and an IV morphine positive control arm.
The primary efficacy endpoint is the proportion of responders to study medication based on their pain numeric rating scale (NRS) at the end of the randomized 24-hour treatment period.
Safety and tolerability will be assessed by respiratory depression adverse events (AEs), sedation AEs, the use of rescue antiemetics, clinician- and patient-reported satisfaction, and other measures.
The study was developed based on feedback from the Chinese National Medical Products Administration (NMPA). Following study completion, Nhwa expects to have sufficient clinical data, accompanied by Trevena’s existing clinical data, to submit OLINVYK for regulatory approval in China.
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