FYI - Publication and Presentations of OLINVO -10/25/17 Trevena Announces Publication and Presentations of OLINVO™ (oliceridine injection) Clinical Data
10/25/17
– American Society of Anesthesiologists Annual Meeting presentations highlight OLINVO data from positive Phase 3 trials –
– OLINVO Phase 2b data published in Journal of Pain Research –
CHESTERBROOK, PA, October 25, 2017 - Trevena, Inc. (NASDAQ: TRVN) today announced that it presented two posters describing the results of APOLLO-1 and APOLLO-2, the Company’s two successful Phase 3 pivotal efficacy studies of OLINVO, at the 2017 Annual Meeting of the American Society of Anesthesiologists (ASA) held in Boston from October 21-25, 2017. The Company also announced that results of its Phase 2b trial of Breakthrough Therapy-designated OLINVO (oliceridine injection) have been published in the peer-reviewed Journal of Pain Research.
“I’m pleased to see continued peer-reviewed publication and presentation of our head to head comparisons of OLINVO to IV morphine,” said Maxine Gowen, Ph.D., chief executive officer. “We know physicians and hospitals want to understand how a new therapy compares to current options. All too often new medications are launched without this data. With growing recognition that the burden of opioid-related adverse effects remains high, but that IV opioids remain necessary medications for many hospital patients, we look forward to submitting our NDA this month in the expectation that OLINVO will become a new option to help hospitals and healthcare providers better manage their patients’ pain.”
Presentations at American Society of Anesthesiologists (ASA)
At the ASA meeting, the Company presented data from both Phase 3 APOLLO studies. The data highlighted the significant and rapid efficacy of OLINVO in managing moderate-to-severe acute pain, and included head-to-head comparisons to IV morphine demonstrating improvement on multiple measures of respiratory safety and postoperative nausea and vomiting. These data suggest that OLINVO has the potential to be a valuable new analgesic option for patients at risk of opioid-related adverse events. Abstracts from the ASA presentations are available online:https://www.abstractsonline.com/pp8/#!/4328/presentation/16988;https://www.abstractsonline.com/pp8/#!/4328/presentation/11614
In addition to these two presentations, the Company sponsored a disease awareness booth at the ASA meeting to help educate attendees on advances in opioid pharmacology, and potential impact on the clinical and economic consequences of opioid-induced respiratory depression and post-operative nausea and vomiting.
Publication of Phase 2b data
Full results of the Company’s Phase 2b trial have been published in the Journal of Pain Research. In this randomized, controlled, double-blind Phase 2b study, intravenous OLINVO demonstrated rapid and powerful analgesic efficacy with statistically significantly reduced frequency of opioid-related adverse events including nausea, vomiting, and respiratory safety events compared to intravenous morphine. This study was the basis for the two successful APOLLO Phase 3 pivotal efficacy studies of OLINVO. The full publication is available online: https://www.dovepress.com/getfile.php?fileID=38764