Drugs

Trevena Resubmits NDA for Pain Drug

Trevena has resubmitted its NDA for oliceridine for managing moderate-to-severe acute pain. The company expects a six-month review by FDA.

The submission is based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on a 2018 complete response letter. It includes data from the multi-dose healthy volunteer QT study, nonclinical data that confirmed levels of an inactive metabolite, and drug product validation reports, the company says. The resubmission package also identified a maximum daily dose of 27 mg, as previously acknowledged by FDA in their Type A meeting minutes, it says, adding that no efficacy data or additional comparative data were requested.

The complete response letter followed a 10/2018 mixed vote by FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. Panel members voted 8 to 7 to recommend not approving Trevena’s next-generation opioid oliceridine injection. In a briefing document released in advance of the meeting, FDA medical reviewers raised safety concerns. Their overall assessment of abuse-related data from clinical studies led to a finding that oliceridine has an abuse potential, overdose potential, and ability to produce physical dependence that is similar to other such treatments.

Trevena describes oliceridine as a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects, the company says.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome