In December 2012, a group of experts in pharmaceutical drugs was called together by the Food and Drug Administration to provide an opinion on whether or not it was a good idea to permit the manufacture of a new painkiller formulation. The manufacturer was Zogenix. They wanted to sell a new pain pill that contained only hydrocodone, a synthetic opiate.
This panel recommended not approving this new drug. Why? Because formulations containing hydrocodone are among the most popular drugs abused by the addicted.
A Little Background on Hydrocodone and Opiates
Two of the most popular prescription opiates that opiate addicts look for are oxycodone (brand named OxyContin, Percodan and many other names) and hydrocodone. Up to now, hydrocodone has been found in small doses combined with large doses of acetaminophen, best known as Tylenol. This combination is brand-named Vicodin, Lortab, Lorcet and a number of other names. A popular combination is a pill that contains about 10 mg of hydrocodone to 325 mg of acetaminophen.
Some reports say that hydrocodone was combined with acetaminophen to discourage abuse. Many people know that high dosages of acetaminophen can destroy one’s liver. But amazingly, these combination pills are still the favorites of many addicts.
Just to get a measure of the popularity of these drugs, in an informal survey of 70 addicts who entered a Narconon rehab center in 2012, 89 percent had abused prescription opiates. And the ones who hadn’t wear primarily alcohol users.
So… Back to Zogenix
Zogenix wanted to sell a pill called Zohydro. It would be an all-hydrocodone pill. The panel of experts shot it down.
In October 2013, the FDA overruled their experts and announced the approval of the all-hydrocodone pill, to be put on the market in about four months.
Given the problems that already exist with opiates, this approval is shocking.
A Spot of Good News
But there is some good news. Also in October 2013, the Food and Drug Administration announced that it would be proposing to the Department of Health and Human Services that hydrocodone-combination products like Vicodin be moved to a more restricted category of drug. When a drug has the potential to be abused by many people and is addictive, it tends to be more closely regulated. It is more difficult to get and there are more laws in place to control its distribution. There will be closer monitoring of the prescribing records. Right now, hydrocodone-acetaminophen is in a category of regulation called Schedule III. The FDA proposes moving it to Schedule II where it will join codeine, opium and morphine.
This action is a step in the right direction, but if at the same time new drugs with high abuse potential are made available, are we really solving the problem?
http://www.sciencedaily.com/releases/2013/12/131202121312.htm
http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-newsArticle&ID=1868848&highlight=
http://en.wikipedia.org/wiki/List_of_Schedule_II_drugs_(US)
https://www.drugfree.org/join-together/addiction/fda-panel-votes-against-recommending-zohydro-for-approval