CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV oliceridine, the Company’s lead investigational product for the management of moderate-to-severe acute pain. The Company anticipates a six-month review period by FDA.
The NDA for oliceridine was resubmitted based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on their Complete Response Letter (CRL). The resubmission package included data from the multi-dose healthy volunteer QT study, nonclinical data that confirmed levels of an inactive metabolite, and drug product validation reports. The resubmission package also specified a maximum daily dose of 27 mg, as previously acknowledged by FDA in the Type A meeting minutes. No efficacy data or additional comparative data versus IV morphine were requested as part of the CRL.
“The resubmission of the oliceridine NDA represents a significant milestone for the program and an important achievement for the company. I am thankful for the team’s commitment and diligent work to bring us to this exciting point,” said Carrie Bourdow, President and Chief Executive Officer of Trevena. “We appreciate FDA’s guidance through the resubmission process and look forward to continuing to work closely with the Agency as they review our application.”
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA 19087
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