Earlier this month, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee overwhelmingly voted against recommending approval of Zohydro ER, an extended-release version of hydrocodone. If approved, Zohydro ER would have been the first hydrocodone medication available that did not also contain a non-opioid analgesic such as acetaminophen or ibuprofen.

While the FDA does not have to follow the recommendation of its advisory committee, it usually does. The final determination is expected to be made by March 1, 2013.

Despite the fact that Zohydro ER was studied in nearly 1,500 patients––some for as long as a year––and found to be generally safe and well-tolerated with no new or unexpected safety problems, panel members expressed concerns with potential abuse, addiction and long-term safety.

It was noted that the manufacturer didn't offer any solution as to how they would limit unintended use other than the already tight distribution channels. Another problem for the panel was that Zohydro ER did not contain any tamper deterrent.

If Zohydro ER, or any other single-entity hydrocodone (without acetaminophen or ibuprofen), is ever approved, it would be considered a Schedule II controlled substance––much more restricted than the current hydrocodone/acetaminophen or ibuprofen combination medications, which are Schedule III.

My Thoughts...

I'm extremely disappointed in the panel's decision. Although the FDA is not required to follow their recommendation, the 11-2 vote against approval and the fact that they usually follow their advisory committee's recommendations makes it highly unlikely that Zohydro ER will be approved.

I feel like both state and federal government officials are falling into what could almost be called mass hysteria when it comes to opioids. They are in such a panic about rising drug abuse that they are enacting extreme laws and placing severe restrictions on even legitimately prescribed opioid medications. They don't seem to realize (or care?) that there are unintended consequences, which can be devastating for chronic pain patients.

My personal opinion is that this advisory committee was simply caught up in the hysteria. I think they were extremely afraid of approving another drug that might be abused by some even though it would potentially help a lot of people living in chronic pain. The real kicker here is that Zohydro ER would actually be much safer for pain patients who have to take hydrocodone for an extended period of time than the current hydrocodone products because it does not contain acetaminophen, which increases the risk of liver toxicity in long-term users.

There might be some justification for the rigid restrictions if they truly helped reduce drug abuse, but as I reported to you about six months ago, the abuse-deterrents are not reducing drug addiction. The addicts are merely finding a way around the deterrent or switching their drug of choice––usually to a much more dangerous drug.