Last week FDA for the first time requested that a pharmaceutical company take an opioid drug off the market due to allegations of abuse. FDA stated that it determined that the benefits of the drug – Opana ER made by Endo Pharmaceuticals – outweighed the risks.
FDA stated in its announcement that Opana ER is often snorted and injected not according to its instructions; it also is linked to the spread of HIV/AIDs, hepatitis C, and a blood clotting disease known as thrombotic microangiopathy.
According to FDA Commissioner Scott Gottlieb, MD, the country is facing a serious opioid epidemic, and FDA must take drastic steps to reduce the problem of opioid misuse and abuse. Gottlieb stated that the agency will continue to take necessary regulatory actions when it sees a situation where an opioid drug risks are more than the benefits. This includes not just for the intended population of patients but also for people who may misuse and abuse the drug.
This act by FDA could indicate that the new FDA commissioner is taking a hard line stance on the prescribing of painkillers, which has set the table for a serious overdose epidemic of the painkillers.
— U.S. News (@usnews) June 16, 2017
Opana ER (extended release) was invented and manufactured by Endo Pharmaceuticals and was approved by the agency in 2006. However, research showed that some users were abusing the drug by crushing and snorting the drug – thus delivering 12 hours of the drug in seconds. Endo then brought out a redesigned Opana ER in 2012. This version featured a harder shell that the company claimed would make the drug harder to crush into powder.
However, FDA determined that the reformulated drug was even more likely to be abused. Instead of crushing it into powder and snorting it, the pills were modified by abusers to inject them. This partially led to a number of thrombotic microangiopathy deaths, and also an HIV outbreak in 2014 and 2015.
Experts say that FDA’s decision to ask Endo to pull Opana ER from the market does not mean that the opioid is easier to abuse than drugs still on the market. But it does say that the current version is actually at higher risk for abuse than the old one. Opana ER is very similar chemically to many other painkillers.
Painkillers that come in high dose pills are very easy to abuse. Without sufficient tolerance to opioids, experimenting with a single 80 mg Oxycontin pill can lead to a serious overdose.
Critics contend that even with versions of opioids that are allegedly harder to abuse, they still can be abused. These newer versions of the pills are supposed to be harder to crush/dissolve, but drug addicts still find ways to adulterate them.
Endo has stated that it is reviewing the request to pull the drug from the market and is currently reviewing the possible options.
FDA Wants to Better Scrutinize Opioid Painkiller Abuse
The recent action by FDA in this case shows that the agency wants to look more closed at the anti-abuse efforts that companies make on opioid painkillers to see if they actually are effective in curtailing drug abuse.
This week, FDA stated that it is going to hold a July 10-11 public meeting that will study if the agency has enough information to find out if the reformulated opioids have any significant effect on limiting drug abuse.
The FDA commissioner has stated that abuse-deterrent opioid formulations are important to focus on at the agency. The most common protections used are special drug coatings and additives that reduce the euphoric effects that the manipulated drugs can have. But Gottlieb added that there is insufficient understanding about if the products really lead to a decrease in the level of opioid abuse in the country.
FDA mandates that companies that sell the abuse-deterrent drugs to do post-approval clinical studies to determine what the effects are, but these studies are hard to do.
This move is another indication of how seriously FDA is now taking the opioid problem in the country. FDA’s Center for Drug Evaluation and Research (CDER) stated last week that figuring out how well abuse-deterrent drugs work is hard because many of the drugs are being taken against prescription and illegally. Thus it is difficult to find reliable data on the practice.
FDA in recent years warned that ‘abuse-deterrent’ drugs are hard to make ‘abuse proof.’ These formulations cannot stop a person who has been prescribed a medication from taking extra pills of the prescription to get high. FDA also has a goal to ensure that opioids are readily available to people who really need them. For this reason, totally stopping the abuse is difficult.