FDA meetings in July to address naloxone use, reformulated OxyContin

June 18, 2015

At the first meeting, stakeholders will explore ways to make naloxone more widely available. At the joint meeting, participants will evaluate post-marketing data for reformulated OxyContin.

FDA has announced its plans to hold a scientific workshop July 1 and 2 on naloxone uptake and use in specific medical and nonmedical settings to reduce fatalities associated with opioid overdose.

In addition, two FDA committees will hold a joint meeting July 7 and 8 to discuss data from postmarketing studies that evaluated the misuse and/or abuse of reformulated OxyContin (oxycodone hydrochloride) extended-release tablets, developed by Purdue Pharma L.P.

The July 1 and 2 meeting is open to the public and will provide time for discussion about which populations are at risk for opioid overdose and how public health groups can collaborate and use naloxone to reduce the risk of opioid overdose. It will also explore ways to make naloxone more widely available. For more information, click here.

The July 7 and 8 meeting brings together the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether the postmarketing results of reformulated OxyContin have helped deter OxyContin abuse. For more information, click here.

The meetings are held in collaboration with the National Institutes of Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration.