FDA Dismisses Elite’s SequestOx Opioid Application

The FDA has rejected Elite Pharmaceuticals’ application for SequestOx over persistent safety concerns about the opioid candidate.

FDA declined the abuse-deterrent opioid candidate’s approval based on seven issues, the most critical of which was safety concerns due to delayed opioid release when consumed alongside fatty foods consumption.

“The extent of the delay in the absorption and the de-concentration of oxycodone from SequestOx under the fat conditions is unacceptable, putting its patients at risk for unintentional overdose,” company officials said, relaying information from the agency’s complete response letter.