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committee testimony

FDA Committee Votes Against Approval of New Opioid

On June 26, advocates of the Steve Rummler HOPE Network testified to an FDA panel opposing the approval of a powerful new extended-release opioid, Remoxy™. Executive Director, Lexi Reed Holtum was joined by board member, Michael Daub and medical advisory committee member, Dr. Andrew Kolodny. The FDA advisory committee voted against the approval of the drug 14-3. The manufacturer, Prime Therapeutics, lists Remoxy™ as their lead product; an alternative to OxyContin. The drug is an abuse-deterrent, extended release formulation of oxycodone. A gel capsule to be taken twice-daily. Michael Daub quotes the National Academy of Science’s 2017 Report in his testimony,

“There is evidence that the long-term use of opioids for the management of chronic non-cancer pain increases the risk of adverse outcomes, such as opioid use disorder and overdose, without clear evidence supporting the appropriateness of such uses.”

He continued expressing his concerns, “The opioid epidemic is engulfing America. I have watched many heartening recovery successes. I have observed far too many fail, succumbing to active addiction again and again. Barely a week goes by where I don’t learn that someone had died of an overdose. Sometimes two or three. Sons, daughters, parents, friends, neighbors. Good people felled by a pernicious, unforgiving, relentless malady. It annihilates all things worthwhile in life. It engulfs all whose lives touch the sufferer’s. It brings misunderstanding, fierce resentment, financial insecurity, disgusted friends and employers, warped lives of blameless children, sad wives and parents.”

We don’t need another powerful opioid on the market. In the biopharmaceutical industry, we must invest in alternative, non-addictive, non-opioid methods and medicines to manage pain. Abuse-deterrent is not addiction-proof or any less deadly.

The advisory committee’s decision does not bar approval of the drug. Remoxy™ has been rejected by the FDA in previous years. We can only hope the FDA follows the committee’s latest recommendations. The FDA will decide by August 7.

United we shape thoughtful policies, educate the public and demand action. You have a voice, a story, a network. Join our advocacy network and be heard.

Join hundreds working to change the course of the opioid crisis and rebuild communities.

Sean O'Donnel


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