Olinvo · Acute moderate-to-severe pain
Development and Regulatory status
Jun 19: Trevena has licensing agreements in two ex-US countries: South Korea and China .
Jun 19: Topline data from the healthy volunteer study anticipated Q4 19 .
May 19: Trevena reports that the FDA has confirmed that the healthy volunteer study can be conducted over a 24-hour period. The study will be performed at a single site as a three-period crossover design that includes oliceridine, placebo, and moxifloxacin as a positive control. The Company plans to submit data on approximately 60 participants. Among this study population, a minimum of 20 participants will receive a cumulative dose of 27mg oliceridine, the proposed maximum daily dose, through the 24-hour study period . The study remains on track to initiate by the end of June. .
Mar 19: FDA has revoked breakthrough therapy status following review of PIII results. The FDA has agreed that it will consider refiling of oliceridine (max 27mg daily) if a PI study in healthy adults is undertaken to provide all-clear on QT interval concerns .
Jan 19: Following the FDA response letter in which additional clinical data were reqested on QT prolongation, Trevena said it will submit a detailed protocol and analysis plan to the FDA and, following feedback, will initiate the required study in H1 2019. Trevena also noted that the FDA requested a study in healthy volunteers to collect the requested QT interval data which it will address.
Nov 18: The FDA declined to approve oliceridine. This was due to inadequate safety data to support its proposed dosing as well as its abuse and overdose potential.
Apr 18: Trevena announces agreements with companies in South Korea and China to commercialise oliceridine in those countries. The Company remains in active discussions for licensing oliceridine in additional territories .
Nov 17: NDA submitted to FDA .
Feb 17: Trevena plan to submit MA to FDA Q4 2017 .
Feb 16: Following two successful PII studies, oliceridine is now in PIII development. The ATHENA-1 safety and tolerability study is ongoing, with pivotal studies expected to begin in Q2 16 .
Feb 16: Granted breakthrough therapy status in US. Already has fast track status .
Trial or other data
Feb 17: Trevena announce top line results from two PIII studies APOLLO-1 (NCT02815709) and APOLLO-2 (NCT02820324). In both, all dose regimens (0.1 mg, 0.35 mg, and 0.5 mg on-demand doses) achieved their primary endpoint of statistically superior responder rates vs placebo (p<0.05 for all comparisons). APOLLO-1 and APOLLO-2 evaluated oliceridine’s efficacy in patients for 48 hours following bunionectomy and 24 hours following abdominoplasty, respectively .
Feb 16: PIII ATHENA-1 study (NCT02656875) is currently recruiting pts in the US. 900 patients with moderate to severe pain caused by medical conditions or surgery, who require IV opioid therapy will be enrolled in this open label safety study & treated with TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined by the investigator, for a duration not to exceed 14 days. The study is expected to complete Mar 17 .