The FDA's Dilemma With The Opioid Pain Medication Zohydro ER

Late last year, the FDA approved a long-acting version of the opiate, hydrocodone. Sold as Zohydro ER by Zogenix , this drug is approved for the management of pain, but is reserved only for use in patients for whom other pain treatments are ineffective or not tolerated. What was surprising about the FDA approval was that the FDA’s Anesthetic and Analgesic Drug Advisory Committee, made up of independent experts, had voted against approval of Zohydro ER by an 11 – 2 vote. The panel was supportive of the drug, but concerned about its abuse potential. While the FDA isn’t bound by the views of its Advisory Committees, it usually follows their advice.

The approval of Zohydro ER, which is slated to reach the market this month, has caused a tremendous uproar. Critics have major concerns about the abuse potential of this drug as it is the first prescription narcotic that provides a pure dose of hydrocodone at a dose much higher than found in other pain pills like Vicodin. There have been bills introduced both in the House and Senate which seek to have the FDA withdraw the approval of Zohydro ER. Sen. Joe Manchin of West Virginia, one of the leaders of this effort, said the following.

“Because of this painkiller’s high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country. The prescription drug epidemic has already damaged and destroyed the lives of far too many individuals and families, and hydrocodone is one of the most abused substances out there. The last thing we need is a drug on the market with 10 times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual in just two tablets.”

Was the FDA asleep at the wheel on this one? What were they thinking when they approved such a dangerous drug?

Actually, they were probably thinking about the patients, the ones who are suffering constantly and for whom nothing works to alleviate their pain. The following view is from a former colleague, Dr. Ethan Weiner. Dr. Weiner spent the first part of his career as a rheumatologist on the faculty of the University of Connecticut School of Medicine treating many patients with chronic pain. He then moved on to Pfizer running clinical trials looking for new treatments for pain and arthritis. An expert in this field, Dr. Weiner recently shared his thoughts with me on these medications.

“Although these drugs have significant abuse potential, that does not negate the fact that there are significant numbers of people suffering chronic pain who cannot live a functional - or even a remotely tolerable - life without them. Their suffering is always overlooked in efforts to prevent this class of drugs from being misused. It is not their fault that others abuse these drugs or that science has failed to provide them effective alternatives less prone to addiction and a host of other dangerous opiate side-effects. There are many promising approaches currently being researched both in academia and within the pharmaceutical industry that hopefully will lead to better alternatives. Until then, however, any alternative, however flawed, that is currently available for people suffering intractable pain should not be denied them.”

Dr. Weiner is right. How can we deny patients in need the access to medicines that can restore them to a more normal life?

He also has a major issue with the involvement of Congress with this process.

“The decision to override FDA’s approval would essentially be a political one coming from Congress. It would be an unprecedented event to overrule a scientific determination by FDA made upon careful evaluation of known and potential risks vs. demonstrated benefits of new agents. Although I haven’t always agreed with FDA assessments of agents that I have helped to develop, I have never seen FDA scientists deviate from careful, thorough, balanced and scientifically rigorous evaluation divorced from considerations of what is politically expedient or popular. To cloud such deliberations with threats of a Congressional override every time they make an unpopular decision would be bad for all involved. The major casualty would be public health.”

In all likelihood, the FDA will bend to this Congressional firestorm and will hold another Advisory Committee to revisit Zohydro ER. I am not sure, however, that the FDA will change its stance. We cannot abandon those in need because of the illegal abuse potential of opioids. My guess is that heart-wrenching testimonies by patients at such a meeting will be convincing enough to allow Zohydro ER to stay on the market but with the strictest prescription controls put on it as possible.

But this all might be moot in a few years. Purdue Pharmaceuticals has recently announced that they are developing a tamper-resistant form of hydrocodone, that could supercede Zohydro ER because the design of their new drug makes it difficult for drug abusers to crush the pill and inject of snort its contents. Until then, patients in need should be allowed access to Zohydro ER.