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Trevena Reports Full Year 2016 Earnings
Two positive Phase 3 pivotal efficacy studies of OLINVO (oliceridine injection) completed
OLINVO program on track for NDA submission in fourth quarter of 2017
Company to host conference call at 8:00 am EST today, to include additional data from recently completed Phase 3 APOLLO trials
Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the fourth quarter and full year ended December 31, 2016 and provided an update on its ongoing clinical programs, including additional data from the recently completed Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy studies of OLINVO in moderate-to-severe acute pain.
The recent successful completion of the pivotal efficacy studies for OLINVO puts us in a strong position to bring this innovative analgesic to physicians and patients in need of a new option for managing moderate-to-severe acute pain in the hospital, said Maxine Gowen, Ph.D., chief executive officer. We believe the data from these studies highlight the potential for OLINVO to reduce the burden of opioid-related adverse effects, particularly for those patients who are at elevated risk for serious consequences from post-operative nausea and vomiting or opioid-induced respiratory depression.
2016 and recent corporate highlights
· Obtained Breakthrough Therapy Designation for OLINVO. In February 2016, the Company announced that the U.S. Food and Drug Administration (FDA) had awarded OLINVO Breakthrough Therapy status, a designation granted to new therapies intended to treat serious conditions and for which preliminary clinical evidence indicates that the drug may demonstrate substantial clinical improvement over currently available therapies.
· Successful End-of-Phase 2 meeting with FDA. In May 2016, the Company announced that it had reached general agreement with the FDA on key elements of the Phase 3 OLINVO program to support a New Drug Application (NDA), including that the APOLLO-1 and APOLLO-2 pivotal efficacy trials in bunionectomy and abdominoplasty included appropriate patient populations to support an indication for moderate-to-severe acute pain.
· In February 2017, announced positive top-line results from two Phase 3 pivotal efficacy studies of OLINVO in moderate-to-severe acute pain. OLINVO demonstrated fast onset and strong opioid efficacy in hard tissue and soft tissue pain models, supporting the Companys planned NDA submission and a potential indication for the management of moderate-to-severe acute pain. Numerous measures of respiratory safety and gastrointestinal tolerability all showed trends of meaningful improvements for OLINVO compared to a commonly used IV morphine regimen.
· Initiated Phase 3 ATHENA open label safety study of OLINVO. In January 2016, the Company announced the launch of the OLINVO Phase 3 clinical program with the enrollment of patients in the open label Phase 3 ATHENA study. This study is evaluating the safety and tolerability of OLINVO in
The following information was filed by Trevena Inc (TRVN) on Wednesday, March 8, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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