Manufacturer Calls on FDA to Deny Mallinckrodt Opioid an Indication for Chronic Pain

Contract manufacturer Pharmaceutical Manufacturing Research Services (PMRS) petitioned the FDA to deny approval to Mallinckrodt subsidiary SpecGx’s opioid for multiple indications, such as control of chronic pain.

The company also called on the agency not to support any treatments that rely on Roxicodone as their reference listed drug, including SpecGx’s opioid, an immediate-release oral tablet formulation of oxycodone that is designed to withstand common manipulation methods and deter abuse.

PMRS expressed concern that patients in the U.S. are taking opioids to manage their chronic pain and, in the long run, are being harmed more than they are being helped by approved drugs that don’t show convincing evidence of efficacy.

“By approving opioids indicated for the treatment of chronic pain without substantial evidence of their efficacy for this indication, the FDA has helped to facilitate the launch of the U.S. opioid epidemic—an escalating public health crisis unprecedented in our country,” PMRS said.