> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Misses User Fee Date on Pain Drug
- URL: https://www.fdaweb.com/fda-misses-user-fee-date-on-pain-drug/
- Published: 2016-10-14T12:00:00.000Z
- Updated: 2026-09-14T21:39:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137076

FDA has told Egalet Corp. that it will not meet a previously announced 10/14 user fee review target date for the pain drug Arymo ER (morphine sulfate). The agency said the delay is centered on the product label, according to the company. “The FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDAs, and confirmed that no additional scientific information or data is needed for our application,” it says.

In August, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 to recommend that the NDA be approved for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Panel members also voted to support the formulation’s abuse deterrent labeling. They mostly agreed that the product should be labeled as an abuse-deterrent product when used by nasal and intravenous routes of abuse. They also recommended that the label should discuss that the drug deters abuse via oral route.

If approved, Arymo ER would be the first product developed using Egalet’s proprietary Guardian Technology — a physical and chemical barrier approach to abuse-deterrence that results in tablets that are difficult to manipulate for the purpose of misuse and abuse, the company says.