Zohydro is a new opiate based pain medication slated for release. The medication is a pure hydrocodone pill meant to treat pain the same way as Oxycontin. Originally scheduled for March 1, a press release from late last month announced that the FDA needed a few more weeks to decide. The FDA did not provide any reason for the possible delay, except for saying that the delay may last only several weeks. Well the delay has still lasted late into September with no recent updates or word as to when it will be approved.
In December 2012, the FDA advisory assembly voted against recommending approval of Zohydro due to concerns about Zohydro’s potential for addiction. In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone. Zohydro may still have a chance, as FDA officials said they could still approve the painkiller by imposing safety restrictions. This is what is causing the delay on approval.
Zohydro is an extended release prescription painkiller containing pure hydrocodone, the opioid also found in Vicodin. If you’ve ever read the label on your Vicodin prescription bottle, you’ll see that Vicodin is usually about 1 part hydrocodone to 100 parts acetaminophen. Acetaminophen may cause liver injury when used in high dosages, which is why doctors usually limit the amount of Vicodin pills you can take per day.
Although this protects your liver, you may not get complete pain relief. Many of your over-the-counter drugs also contain acetaminophen, so it’s very easy to inadvertently consume more than you should. Continually consuming too much acetaminophen will progress to permanent liver damage. Research shows that acetaminophen toxicity is one of the leading causes of liver failure and the second most common cause of liver failure requiring transplantation. It may not kill you, but liver failure is not a condition to be scoffed.
This is why pharmaceutical companies like Zogenix are so keen to give us Zohydro. Zohydro contains only the opioid hydrocodone. Zohydro can come in two forms: an immediate-release medication and an extended-release medication. As an extended-release medication, Zohydro has the ability to provide around-the-clock pain relief without the risk of liver failure. This combination makes Zohydro attractive to the millions of people suffering from chronic pain—as well as individuals who are addicted to painkillers.
Considering that Vicodin and Oxycontin are the two most abused prescription drugs in the nation, it’s no surprise that the FDA is hesitant to release a drug similar to both these medications. Though even with the risks of abuse, it seems that it would be a no-brainer to approve Zohydro. It provides a safer alternative to medicines with acetaminophen and an alternative option to Oxycontin. Oxycontin already comes in both instant and extended release forms as will Zohydro, so it is not like the medication will be some totally new and risky format. It is already acknowledged to be a schedule II narcotic making it much harder to get easily and abuse.
At the risk of sounding like a conspiracy theorist, the question that is raised in my mind is what’s going on behind the scenes for the delay? Purdue pharma, the company that makes Oxycontin is notoriously defensive of their product, and for good reason too. Since it’s release in 1996 Oxycontin has made 27 Billion dollars for Purdue. Recently they have been in legal battles over the patent expiration of the original abusable 80mg Oxycontin formulation. What this means is that since the patent is expired other pharmaceutical manufacturers will be able to produce generic 80mg Oxycontin. Purdue sees this as a threat to their market share and have been fighting furiously this year to get a patent extension so no others will be able to produce it. They say that it is to help curtail the drug abuse but I say it is just because it is in their best interest to continue to line their pockets.
They also recently came under some scrutiny because they have a list of about 1,800-2,000 doctors they believe are prescribing Oxycontin unethically. This list is private and known only higher ups at Purdue. They only recently released the names of 154 to law enforcement. Only 154 out of 2,000 is a miniscule amount, even 2,000 seems like a small amount compared to the amount of drug abuse and deaths related to Oxycontin. Giving up only 154 is like throwing a small bone to law enforcement and they only did so when it gave them a market advantage to do so. They should have a moral and ethical responsibility to report the full list but they don’t. Why would they, the doctors on the list more than likely produce a huge amount of revenue in Oxycontin sales. No cartel would willingly give up it’s best drug dealers. In my opinion its legalized drug dealing. After looking at this past behavior it is easy to see that its possible Purdue doesn’t want a competing company with a similar product taking away their market share. To use the drug dealer analogy again, it’s like having another drug dealer set up shop on the corner across the street from another.
I’m not saying that the reason for the delay in approval is because of shady behavior behind the scenes, but it is possible and just something to think about. In other news, surprisingly or unsurprisingly there are no new non-opioid painkillers on the horizon being researched or tested. The truth is that opioid painkillers work and work well. They are also highly abused despite how well they work for legitimate pain. There should be more money devoted to research on non-opioid based pain medication that work for high levels of acute and breakthrough pain. As well as how to change the way we look at drug abuse and addiction in this country. Opioid abuse is damaging to a persons health, both physical and mental. And medical doctors should be practicing medicine in a manner that causes the least amount of harm. There’s actual damage done, not just some amorphous abstract ethical question. It has very concrete effects on individuals and society as a whole.
C.S. Bridger is an LA based writer and photographer trying to make sense of recovery