CDER Denies Petition to Stay Approval of Abuse-Deterrent Opioid

The FDA declined a request from Pharmaceutical Manufacturing Research Services (PMRS), a contract drug manufacturer, to stay the approval of RoxyBond, Inspirion’s immediate-release abuse-deterrent opioid.

PMRS submitted the petition in May soon after the FDA approved RoxyBond as the first immediate-release opioid analgesic with abuse-deterrent label claims, claiming the associated safety hazards would tarnish the reputation of all abuse-deterrent opioids, including a product developed by PMRS.

In a response to the petition, CDER Director Janet Woodcock said the company had failed to demonstrate that the launch of Roxybond would cause it irreparable injury.