Trevena, Inc. Announces Receipt of Type A Meeting Minutes and Provides Regulatory Update for Oliceridine New Drug Application
January 28, 2019 at 07:00 am
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Trevena, Inc. announced the receipt of the official Type A meeting minutes from the U.S. Food and Drug Administration 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. 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.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of medicines for patients with central nervous system (CNS) disorders. The Company has one approved product in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Companyâs pipeline includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder. TRV045 is a novel, highly selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. TRV734 is a small molecule G-protein biased ligand of the mu opioid receptor (MOR).
TREVENA, INC. 
