(A courtroom in the United States, December 2016)
“Doctor…Why did you prescribe Zohydro to the plaintiff’s son in July 2015?”
“He was experiencing severe pain as a result of his fall, and I had positive experience in using Zohydro with this type of case.”
“Were you aware that he had a history of abusing opioid painkillers?
“No, I was not.”
“But were you aware that there was an abuse-deterrent version of hydrocodone, also acetaminophen-free, that was available?
“Yes, but since he was having good results with Zohydro, I did not want to take the risk of switching him to a new drug.”
“Doctor, isn’t it likely that, had you prescribed the abuse-deterrent form of the drug instead of Zohydro, that the plaintiff’s son would not have overdosed, and would be alive today?”
As dramatized-for-TV as this vignette may be, it is the reason that Zohydro’s days and prospects are on a finite downslope. There was a valid reason for approving an acetaminophen-free version of hydrocodone, and in spite of the self-serving harrumphs of outrage percolating out of Congress, the FDA was correct in doing so. Congress would be practicing well outside its nanoscale areas of expertise in legislating the components of any pharmacopaeia, and we hope that the FDA will not yield to them now. But with Purdue Pharmaceuticals having completed pivotal testing of an abuse-deterrent formulation that achieves similar analgesic results, the clock is ticking on Zohydro. There will be strong pressure for an accelerated review once that NDA is filed, and even though the Senate’s limited attention-span will doubtlessly have shifted by the time the Purdue drug is approved, prescribing physicians will have had their focus brought to the legal liability they would face if a patient were to overdose on Zohydro when a safer alternative was available–or if a patient driving-while-impaired after crushing and snorting Zohydro were to cross the median into an oncoming school bus–one can paint any number of ruinous malpractice/liability scenarios. The question is not whether the plug will be pulled on Zohydro, but by whom: The FDA, already on record stating that abuse-vulnerable drugs can be pulled from the market when an abuse-deterrent version is ready; or by physicians bent on avoiding the easily avoidable spectre of very public liability. Zogenix has to now decide whether putting resources into their own abuse-deterrent formulation is worth the investment when it would mean going up against a Purdue version that will have had a head start. But their strategic planning had better be predicated upon a rather brief window of opportunity for Zohydro, a window already narrowed by the controversy spurred by its approval and launch.