Panel votes against painkiller
An FDA advisory panel voted 14-0 against QRXPharma's morphine-oxycocdone combination pain medication.
As MedPage Today reports, Tuesday's panel could not support approval based on the drugmaker's data. Among the issues noted, according to MedPage, were panel chair Randall Flick's assertion that QRxPharma “had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone.”
MedPage notes that the FDA has sent two complete response letters to the drugmaker since 2012.
Prescription opioid medications have been a hot topic among lawmakers because of rising abuse rates. The FDA's recent approval of Zohdryo has been a particular lightning rod, triggering a now-overturned Massachusetts ban on the prescription drug, as well as requests that the FDA pull its approval of the easily abused hydrocodone medication.
MedPage indicates that the latter concern did not influence the FDA panel's Moxduo vote, quoting Flick as saying “the committee does not suggest Moxduo is either beneficial or not beneficial; the [committee] simply feels that evidence is insufficient to make a determination either way.”