CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN) announced the receipt of the official Type A meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the oliceridine New Drug Application (NDA).
FDA has agreed that the Company’s current safety database will support labeling at a maximum daily dose of 27 mg.
FDA also has agreed that the Company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms. The Company intends to submit a detailed protocol and analysis plan to FDA shortly and, following receipt of FDA feedback, anticipates initiating this study in the first half of this year. The Company is not required to provide any additional efficacy data to resubmit the oliceridine NDA.
“We are encouraged by the productive discussion with FDA, which we believe has provided a path to resubmit the oliceridine NDA,” said Carrie L. Bourdow, President and Chief Executive Officer. “We remain committed to our mission of ensuring access to safe and effective treatment options for hospital patients who require an IV opioid to manage their moderate to severe acute pain.”
To address other items in the CRL, FDA has indicated that the Company should include supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted.
The Company also announced that it expects cash, cash equivalents, and marketable securities as of December 31, 2018, to be approximately $61.5 million, which the Company anticipates will be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2020. In March 2019, the Company expects to announce full financial results for the fourth quarter and full year ended December 31, 2018.
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA, 19087
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