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Trevena Reports Second Quarter 2017 Financial Results and Provides Corporate Update
OLINVO program on track for NDA submission in September/October 2017
First-time-in-human study of TRV250 for acute treatment of migraine remains on track; results expected in 2H 2017
August 3, 2017 Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the quarter ended June 30, 2017 and provided an update on its pipeline of investigational products.
The second quarter saw continued progress towards our goal of delivering an innovative new option for patients who are at risk of adverse events associated with IV opioids like morphine, said Maxine Gowen, Ph.D., chief executive officer. We have now completed our Phase 3 clinical development for OLINVO and successfully completed our pre-NDA meetings with the FDA. In addition, we have refined our commercial strategy to lay the groundwork for a successful commercial launch. With the comparative data from our successful APOLLO pivotal efficacy studies, as well as data and investigator observations from more real-word use in the ATHENA open label study, we believe the value of OLINVO will resonate with potential prescribers who want to improve the care of hospital patients suffering severe pain.
Second quarter and recent corporate highlights
· OLINVO (oliceridine injection) program remains on track for a new drug application (NDA) submission in September/October 2017. In July 2017, the Company announced that enrollment in the ATHENA open-label safety study was complete to support the NDA file, with 772 patients treated with OLINVO across more than 40 sites. In addition, the Company successfully completed a chemistry, manufacturing, and controls (CMC) Type B pre-NDA meeting and a preclinical and clinical Type B pre-NDA meeting with the U.S. Food and Drug Administration (FDA). All pre-NDA activities remain on track to support an NDA submission to the FDA in September/October of 2017.
· Hosted an Analyst Day featuring four leading experts in acute pain management in the hospital. In July, the Company hosted an Analyst Day where it provided an update on its clinical portfolio, including new data and commercial strategy for the OLINVO program:
· The Company outlined its commercial strategy for OLINVO, including its plans to initially focus on patients who require IV opioids and are at greater risk of opioid-related adverse effects (ORAEs). Specifically, the Company expects to target medical education and post-approval promotion to eight physician specialties with 80 select procedures and diagnoses where pain is most severe and/or prolonged, and where procedure, comorbidity, or demographic factors place patients at elevated risk of ORAEs. These patients comprise approximately 7 to 9 million annual hospital inpatients in the United States.
· New analyses of the Premier Perspective® Hospital Database quantified the clinical and economic burden of illness associated with ORAEs in the 80 procedures and diagnoses where the Company will initially focus its commercialization efforts. These analyses showed that
The following information was filed by Trevena Inc (TRVN) on Thursday, August 3, 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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