An Uphill Struggle for the New Super Painkiller
(page 2)Further, although it’s no secret that hydrocodone is addictive, it may in fact be even more addictive than originally thought. There is a widespread perception that because current hydrocodone painkillers (which are all combined with acetaminophen) are Schedule III drugs, they are less dangerous than oxycodone painkillers, which are Schedule II. (The difference turns on potential for abuse, with II indicating high abuse and III indicating moderate.)
But Dr. Sharon Walsh of the Center for Drug and Alcohol Research at the University of Kentucky presented data at the FDA hearing showing that current drugs with hydrocodone are milligram for milligram only slightly less potent than oxycodone (0.93 mg. of oxy is equal to 1 mg. of hydro). This finding would seem to argue that the two narcotics have the same controlled-substance designation. Further, because Zohydro lacks acetaminophen, its potency may indeed be on a par with oxycodone's.
Zohydro ER, if approved, will be slapped with a Schedule II label in recognition of its potency and addictiveness. Its extended-release formulation warrants maximum vigilance. Information from Drug Abuse Warning Network, presented by Rajdeep Gill of the FDA epidemiology department, shows that the abuse ratio for single-ingredient, extended-release oxycodone products is three to four times higher than combination-oxycodone products. As a result, Zohydro stands a good chance of becoming the drug of choice among opiate addicts, attracting many who have had to switch to heroin following the advent of tamper-proof oxy. In this way, Zohydro risks reversing the sharp decline of oxy addiction and overdoses seen in recent years.
While the advisory committee’s vote against approval is only a recommendation, the FDA rarely goes against its own handpicked advisors.
For now, Zohydro's prospects of making it to market in 2013 are not encouraging. While the advisory committee’s 11-to-2 vote against approval is only a recommendation, the FDA rarely goes against its own handpicked advisors.
Still, the meeting did not lack calls by officials and advocates to give Zohydro a hearing unbiased by the dark legacy of OxyContin. Dr. Bob Rappaport, director of anesthesia, analgesia and addiction products at the FDA, admonished the panelists to distinguish between Zohydro and other opiates lest they be seen as “punishing this company and this drug because of the sins of other companies and their product." In addition, pain patients and their advocates reminded the FDA advisors of the relatively low incidence of addiction among prescription users with chronic pain.
Yet this case for alevel playing field gained little traction given the threat posed by Zohydro ER of a new "oxy epidemic." As one advisor put it, approving a new opioid without tamper resistance would be opening a public health “Pandora’s Box.”
Sacha Z. Scoblic is the science writer at The Fix, the author of Unwasted and a Carter fellow for mental health journalism.