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Trevena resubmits new drug application for oliceridine for the management of moderate-to-severe acute pain.

Read time: 1 mins
Published:11th Feb 2020
Trevena, Inc. announced that it has resubmitted its New Drug Application (NDA) to the 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.
Condition: Pain:Moderate to Severe
Type: drug

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