Shionogi Must Complete Postmarket Studies For Rybix ODT, FDA Says in ‘Untitled’ Letter

The Food and Drug Administration told Shionogi Inc. that it has failed to comply with postmarketing study requirements under the new drug application for Rybix ODT (tramadol hydrochloride), according to an “untitled” letter posted May 23 on FDA’s website.

Rybix ODT is indicated for managing moderate to moderately severe pain in adults, according to Shionogi’s website.

FDA said it notified the company in September 2012 that it needed to conduct two postmarket clinical trials to identify an unexpected serious risk of QT prolongation/torsades de pointes, a heart rhythm abnormality associated with using tramadol.

One of the studies required Shionogi to ...