| 2016-10-19 13:53:06|
TRVN 13:53 10/19 10/19/16
Meet Trevena: CEO Gowen expects new clinical trial data in Q1
In an exclusive interview with The Fly, Trevena's (TRVN) CEO Maxine Gowen discussed the company's primary drug candidate Oliceridine, or TRV130, and its ongoing Phase 3 studies: "We are still expecting to share the top line data from both [Oliceridine] APOLLO studies in the first quarter of 2017 as we have guided. Our goal for Oliceridine is a labeled indication for the management of moderate to severe acute pain. So that means any moderate to severe pain when an IV medicine is appropriate and that's regardless of what causes the pain. According to FDA, you can get a broad label like this or this can be supported by demonstrating efficacy in both the hard tissue and the soft tissue pain in the case study. So that's why our Phase 3 program includes bunionectomy, which is a hard tissue model of bone surgery, and an abdominoplasty trial, which is a soft tissue model. We use both of these models in the Phase 2 trials and from that we generated the very compelling data around Oliceridine's efficacy as well as safety and tolerability compared to morphine. So with those two [APOLLO] pivotal trials as well as the multi procedure ATHENA study, which is a trial we're doing, we believe that we'll have sufficient data to support that broad label indication without the need to do any further trials." "Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. The remainder of this interview to follow.