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Trevena Reports Third Quarter 2017 Financial Results and Announces New Positive Clinical Trial Data
New ATHENA data show OLINVO effectiveness with promising safety/tolerability in key target procedures
Positive interim data for Phase 1 study of investigational migraine treatment TRV250 leads to study expansion
CHESTERBROOK, PA, November 7, 2017 Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended September 30, 2017, and announced positive new data from both its OLINVOTM (oliceridine injection) and TRV250 programs.
The recent submission of the OLINVO NDA capped a transformative period for our Company, said Maxine Gowen, Ph.D., chief executive officer. We are now focused on preparing for the approval and commercialization of OLINVO, while continuing to advance our development pipeline following our recent strategic decision to halt our discovery research efforts. To this end, new results continue to highlight the potential value of OLINVO for patients in a real world setting who require IV opioids but are at risk of opioid-related adverse events. Positive interim Phase 1 data for TRV250 bode well for future clinical development of this exciting potential migraine therapy.
Third quarter and recent corporate highlights
· OLINVO New Drug Application submitted. The Company recently submitted its New Drug Application (NDA) for OLINVO to the U.S. Food and Drug Administration (FDA). OLINVO is the first G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator, and the first pain program to receive Breakthrough Therapy designation from the FDA. The submission includes data showing that intravenous OLINVO demonstrated analgesic efficacy in all three dosing regimens tested in the two Phase 3 APOLLO pivotal efficacy studies. These trials were designed to support an indication for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The filing also includes safety and tolerability data for over 1,100 patients administered OLINVO across Phase 2 and Phase 3 studies, including the ATHENA open label safety study. Additional pharmacokinetic data, clinical pharmacology data, and results from five randomized controlled trials with head to head comparisons to morphine, support potential differentiation of OLINVO.
· New data from Phase 3 ATHENA open label safety study. In July, the Company announced top-line results from the first 418 patients administered OLINVO to manage medical or postoperative pain in the ATHENA study, which was designed to model real-world use including multimodal analgesia regimens incorporating OLINVO. Data for all 768 patients administered OLINVO are now final, and highlight the effectiveness and utility of OLINVO in treating patients who require an IV opioid to manage pain. Across the ATHENA study:
The following information was filed by Trevena Inc (TRVN) on Tuesday, November 7, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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