CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System conditions, recently announced that it has initiated the healthy volunteer QT interval study for oliceridine, the Company’s lead investigational drug candidate for the management of moderate to severe acute pain. The Company remains on track to report topline data in the fourth quarter of 2019 and currently expects to resubmit the New Drug Application (NDA) for oliceridine as early as possible in the first quarter of 2020.
“After receiving feedback from FDA on our proposed healthy volunteer study protocol and statistical analysis plan in mid-May, the team quickly finalized details to ensure a timely study start,” said Carrie Bourdow, President and CEO. “I would like to commend the team for the considerable work they have accomplished to ensure that we reached this significant milestone on time, and we look forward to completing the critical work ahead for a successful resubmission of the oliceridine NDA.”
The primary objective of the study is to collect the additional QT interval data requested by the U.S. Food and Drug Administration (FDA) for the resubmission of the NDA for oliceridine. The study will be performed in healthy volunteers at a single site as a three-period crossover design. Each subject will be randomly sequenced through all three study periods: oliceridine, placebo, and moxifloxacin as a positive control. A short, treatment-free washout occurs between each period. Electrocardiograms for all subjects will be obtained in a rigorous manner throughout the study. The Company plans to submit data on approximately 60 healthy volunteers, and among this study population, a minimum of 20 subjects will receive a cumulative dose of 27 mg, the proposed maximum daily dose of oliceridine.
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA, 19087
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