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Approving Opioid Medication Would Increase, Not Deter, Abuse

June 26, 2018

Approving Opioid Medication Would Increase, Not Deter, Abuse

Public Citizen’s Dr. Sidney Wolfe to Testify Against Remoxy in Front of FDA Panels

The U.S. Food and Drug Administration (FDA) is considering approving a new oxycodone medication that would be marketed as an abuse deterrent, but which actually likely would increase oral abuse, despite the fact that the U.S. already is the world’s largest consumer of opioid oxycodone. Dr. Sidney Wolfe, co-founder of Public Citizen’s Health Research Group, will testify today in front of the FDA Drug Safety and Risk Management and Anesthetic and Analgesic Drug Advisory Committees urging them to recommend that the agency not approve the medication, known as Remoxy.

Remoxy, developed by Pain Therapeutics, is intended to “deter abuse by the oral, nasal and intravenous routes. The proposed indication is the management of pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate.”

However, when Remoxy is chewed, it releases much more oxycodone than when swallowed whole, giving patients a much more rapid release of the opioid, Wolfe will say. Thus it actually is abuse-enhancing. Its modest effects in reducing intravenous and intranasal abuse would be undermined by the oral abuse.

Approving another oxycodone medication is concerning particularly in the midst of an opioid crisis, Wolfe will say. With an estimated 32,128 deaths involving oxycodone occurring from 2010 through 2015 and the U.S. already being the world leader in population-adjusted oxycodone consumption, approving Remoxy could well add to this toll.