Exhibit 99.1

 

Trevena Reports Third Quarter 2019 Results and Topline Data From Multi-Dose Healthy Volunteer QT Study

 

 

Company expects to resubmit NDA for oliceridine in Q1 2020

 

— Acute migraine proof-of-concept study for TRV250 initiated —

 

 

Company to host conference call at 8:30 a.m. EST

 

 

CHESTERBROOK, PA, November 4, 2019 — Trevena, Inc. (Nasdaq: TRVN)

, a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced topline results from its multi-dose QT study for IV oliceridine, reported its financial results for the third quarter ended September 30, 2019, and provided an overview of its recent operational highlights.

 

“We believe the information provided from the multi-dose QT study thoroughly addresses the questions FDA posed to us.  The results show no evidence of an accumulating effect of oliceridine on the QT interval, when administered in repeated doses to the 27 mg proposed maximum daily dose over 24 hours,” said Mark Demitrack, M.D., SVP and Chief Medical Officer.  “These data, alongside the cardiac safety data submitted in the original NDA, provide a comprehensive assessment of the safety and tolerability of oliceridine, and will allow us to move ahead with plans for NDA resubmission in the first quarter of next year.”

 

Recent Corporate Highlights:

 

·                  Completed multi-dose QT study for oliceridine.  No accumulation of effect was observed on the QT interval.  A small, transient effect, consistent with that observed in the single-dose QT study, began dissipating after 12 hours and was absent at the end of the 24-hour study period despite repeated dosing of oliceridine.

 

Oliceridine was well tolerated, with 59 subjects receiving the 27 mg maximum daily dose.  There were no serious adverse events.

 

In addition to this data, the Company previously announced that it has completed the work to address the other items requested by FDA in their complete response letter for oliceridine. The Company expects to resubmit the NDA for oliceridine in the first quarter of 2020.

 

·                  Initiated TRV250 acute migraine proof-of-concept study. This is a single-dose, double-blind, placebo-controlled study with an enrollment target of approximately 120 migraine patients in a validated nitroglycerin (NTG) provocation migraine model. Patients will be randomized before

 


The following information was filed by Trevena Inc (TRVN) on Monday, November 4, 2019 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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