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Trevena Reports Full Year 2017 Earnings
OLINVO (oliceridine) Injection New Drug Application submitted and accepted for review by FDA, with PDUFA date of November 2, 2018
Company to host conference call at 8:00 am EST today
Trevena, Inc. (NASDAQ: TRVN) today announced financial results for the fourth quarter and full year ended December 31, 2017 and provided an update on its pipeline of differentiated new chemical entities, including its lead asset OLINVO (oliceridine) Injection, currently under review by the U.S. Food and Drug Administration (FDA) for potential approval this year.
2017 marked important progress for Trevena as we completed our Phase 3 program and NDA submission for OLINVO and prepared to support commercial launch, said Maxine Gowen, Ph.D., chief executive officer. We look forward to potential approval of OLINVO later this year, as well as advancement of our earlier R&D programs. We remain committed to bringing patients innovative medicines for safer and more successful pain management.
2017 and recent corporate highlights
· New Drug Application (NDA) for OLINVO submitted and accepted. In January 2018, the Company announced that the FDA has accepted the Companys NDA for OLINVO. OLINVO is an investigational product for the management of moderate to severe acute pain. It is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer associated adverse effects. The FDA has informed the Company that it intends to convene an advisory committee meeting to discuss the OLINVO NDA ahead of the Prescription Drug User Fee Act (PDUFA) review date of November 2, 2018. If approved, the Company expects commercial launch of OLINVO in the first quarter of 2019 following DEA scheduling.
· Announced top line data from the successful Phase 3 open label ATHENA safety study. In November, the Company announced top-line results from 768 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 highlight the potential effectiveness and utility of OLINVO in treating patients who require an IV opioid to manage acute pain. Patients at elevated risk of opioid-related adverse events were well represented in the study; more than 30% of patients were 65 years or older, and more than 50% of patients were obese, with body mass index (BMI) >30 kg/m2. Only 4% of patients discontinued for lack of efficacy, and 2% of patients discontinued for adverse events. Adverse event rates associated with OLINVO administered by patient controlled analgesia (PCA) and as-needed clinician-administered bolus dosing were similar, supporting potential use of OLINVO in both administration paradigms.
· Completed dosing in a Phase 1 study of TRV250 for acute migraine. TRV250 is under investigation as a potential new mechanism of action for the treatment of acute migraine. The first-time-in-human Phase 1 trial was a single ascending dose study of safety, tolerability, and pharmacokinetics
The following information was filed by Trevena Inc (TRVN) on Wednesday, March 7, 2018 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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