Endo Pharmaceuticals will have to remove one of its most powerful painkillers from the market due to a decision by the United States Food and Drug Administration on Thursday. The painkiller in question is an opioid of incredible strength called Opana ER, and the FDA claims this is the first instance of a ‘viable’ medication being removed from the market strictly because of the potential for abuse by the public.
The commissioner of the FDA, Dr. Scott Gottlieb, said that every necessary step must taken to prevent the opioid abuse epidemic from growing larger. He went on to say that the FDA will start considering the potential for abuse related to opioid products and will issue regulatory measures when the risks are not overpowered by the benefits of the medication.
Many are probably familiar with Opana ER since it was made popular during the Indiana HIV outbreak of 2015. Most addicts in that region chose Opana ER because it was relatively easy to acquire and it produced the same narcotic effect that many addicts seeks.
In terms of the relative strength of Opana ER, it is certainly comparable to other opioids that are commonly abused. OxyContin is one such commonly abused opioid, and Opana ER is roughly twice as strong as that drug. The majority of patients who are prescribed Opana ER are those who have such severe pain issues that nothing else will work for them. Opana ER has been on the market since 2006.
Before the FDA made their decision, Endo Pharmaceuticals had already attempted to reduce the abuse potential for Opana ER by adding a coating to the pills that was supposedly meant to make the pills nearly impossible to crush, which is the preferred method of ingestion for addicts since the pills are designed to be released over a period of several hours. Crushing the pill allows all the active drug to be absorbed at the same time, creating a stronger high.
The formula for the drug was changed slightly by Endo Pharmaceuticals in 2012, at which point addicts started using needles to inject the drug instead of ingesting it orally. This development is, in part, what led to the spread of HIV in Indiana a few years later. In that case, over 142 people contracted HIV as a result of sharing needles.
The decision made by the FDA was based on the review of data collected since the drug was reformulated. They found that the reformulation caused a shift toward injecting the drug, which had the potential to lead to serious health problems. In March, the agency formed an independent panel of opioid experts that reached the conclusion that the drug no longer provided more benefits than risks.
The United States Centers for Disease Control and Prevention have stated that the country is currently fighting the largest opioid abuse epidemic in history. In 2015, over 33,000 people overdosed and died from opioids, and that figure represented the largest number of opioid overdose deaths ever recorded. When the total number of drug overdose deaths is taken into account, about half of them are attributed to prescription drugs.
In a statement released after the decision by the FDA was announced, Endo Pharmaceuticals announced that it was looking at its options for moving forward. The statement also claimed that Endo feels they are responsible for both creating medications that will alleviate pain in the worst cases and ensuring those medications have the lowest possibility for abuse.
The statement from Endo also reiterated the fact that they believe Opana ER is a safe and effective drug when used as intended, and that their clinical research has all but proven the drug has a positive benefit-to-risk ratio.