- Based on feedback received from the FDA at an End-of-Phase 2 meeting, Trevena (NASDAQ:TRVN) clarifies the key elements of its Phase 3 development program for Breakthrough Therapy-tagged TRV130 (oliceridine) for the treatment of moderate-to-severe pain.
- The Phase 3 program will enroll at least 1,100 patients undergoing bunionectomy (removal of a bunion from the foot) or abdominoplasty (tummy tuck) surgeries in two separate trials. APOLLO-1 will assess oliceridine for 48 hours in patients following bunionectomy while APOLLO-2 will assess the product candidate for 24 hours following abdominoplasty. Each will enroll ~375 subjects. Participants will be randomized to receive one of three regimens of oliceridine via patient-controlled analgesia, morphine or placebo.
- The primary endpoint for both studies will be a responder analysis compared to placebo. A responder will be defined as a patient experiencing at least a 30% improvement in pain versus baseline without early discontinuation and without rescue pain medication.
- Both APOLLO studies should start in Q2. Top-line data are expected in Q1 2017. If successful, an NDA is on tap for H2 2017. The total number of expected subjects is only 750 so another Phase 3 study appears to be in the mix, possibly after the optimal dose of oliceridine is determined.
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Oliceridine, a G-protein-biased ligand that targets the mu opioid receptor, is being developed as a potential replacement of intravenous opioid analgesics. Its value proposition is comparable pain relieving efficacy to morphine while minimizing the unwanted respiratory depression, GI dysfunction (constipation), nausea and vomiting.
- Management will host a conference call today at 5:30 pm ET to discuss its plans.
- Shares are up 5% after hours on increased volume.