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

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.