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Trevena Reports First Quarter 2017 Financial Results and Provides Corporate Update
Successfully completed two positive Phase 3 pivotal efficacy studies of OLINVO (oliceridine injection)
OLINVO program on track for NDA submission in fourth quarter of 2017
Clinical development of TRV250 for episodic migraine initiated with first subjects dosed in Phase 1 trial
May 4, 2017 Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended March 31, 2017 and provided an update on its ongoing clinical programs.
This quarter marked a key milestone for our OLINVO program, with the delivery of robust data that we believe will support our new drug application and demonstrates the potential value of OLINVO for the management of moderate-to-severe acute pain in the hospital, said Maxine Gowen, Ph.D., chief executive officer. There remains a critical unmet need for patients who require IV opioids to manage pain but are at risk for poor outcomes from opioid-related adverse effects. Our successful Phase 3 data showed not only significant efficacy of OLINVO versus placebo to support approval, but also showed the potential for fewer gastrointestinal and respiratory adverse effects while providing comparable pain relief to a commonly used morphine regimen.
First quarter and recent corporate highlights
· Announced positive top-line results from two Phase 3 pivotal efficacy studies of OLINVOTM (oliceridine injection) for moderate-to-severe pain. In February, the Company announced positive data from the APOLLO-1 and APOLLO-2 studies of OLINVO in moderate-to severe-acute pain following hard tissue and soft tissue surgeries, respectively. OLINVO demonstrated significant analgesic efficacy compared to placebo in both studies for all three tested dosing regimens. Consistent with Phase 2b results, a 0.35 mg dose regimen provided comparable pain relief to a common IV morphine regimen and showed potential to reduce opioid-related adverse effects on multiple measures of respiratory safety and gastrointestinal tolerability.
· OLINVO program remains on track for a new drug application (NDA) submission in 4Q 2017. As of March 31, 2017, approximately 600 patients have been treated with OLINVO in the ongoing open-label, multi-procedure ATHENA safety study. In addition, the Company has successfully completed a chemistry, manufacturing, and controls Type B pre-NDA meeting with the U.S. Food and Drug Administration (FDA), and all pre-NDA activities remain on track to support an NDA submission to the FDA in the fourth quarter of 2017.
· Presentation of Phase 3 OLINVO data at medical conferences. In April, the Company announced two presentations of results from the APOLLO-1 and APOLLO-2 pivotal efficacy studies of OLINVO at the 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting, representing the first scientific presentations of the Phase 3 OLINVO data.
The following information was filed by Trevena Inc (TRVN) on Thursday, May 4, 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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