FDA issues complete response for Olinvo in acute pain.- Trevena.

Trevena announced the Company has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Olinvo (oliceridine) for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted. Consistent with the discussion at the recent Advisory Committee meeting, FDA has requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. FDA also requested certain additional nonclinical data and validation reports.

Comment:.Trevena has asserted that oliceridine is safer than currently available intravenous opioids, pointing to the drug's mechanism of action as a key differentiating factor. With this response the agency had not agreed to Trevena's plans to measure oliceridine's impact on respiratory safety burden.