Trevena (TRVN) Resubmits NDA For Pain Drug Oliceridine To FDA
Zacks Investment Research | Feb 10, 2020 09:22PM ET
Trevena, Inc. ( (NASDAQ:TRVN) announced the resubmission of its new drug application (NDA) to the FDA for its lead investigational product - IV oliceridine — for the management of moderate-to-severe acute pain.
Oliceridine is an opioid-based analgesic administered intravenous and also a G protein biased ligand of the mu receptor, which is being developed for managing moderate-to-severe acute pain.
In November 2018, the FDA issued a complete response letter (CRL) with respect to the company’s NDA for oliceridine. In the CRL, the FDA requested additional clinical data on the QT interval and indicated that the submitted safety database was not of adequate size for the proposed labeling. The FDA also requested certain additional nonclinical data and validation reports. In January 2019, the company announced the receipt of the official Type A meeting minutes from the FDA regarding the CRL, wherein the agency agreed that its current safety database will support labeling at a maximum daily dose of 27 mg. 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.
Shares of Trevena have slumped 50% in the past year compared with the Zacks Investment Research
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