The popular opioid Opana ER has been an effective painkiller for over a decade. That all came to an end this week as the FDA announced its removal from shelves. CBS News is reporting that Endo International PLC said Thursday it will voluntarily stop selling the pills after consulting with the U.S. Food and Drug Administration. It’s the first opioid drug that the FDA has sought to remove from the market due to anything other than poorly made products. The issue with OPANA ER is consumer abuse, even as the manufacturer insists it is effective when properly used.
According to CNN, both prescription and illegal opioids are commonly abused because of their addictive properties. They bind to the mood sensory organisms in the brain, increasing the dopamine levels of users. As the brain grows used to the increased dopamine, the user craves the sensation of euphoria that comes with it.
Opana ER is twice as potent as OxyContin, another oft-abused narcotic opioid. Some facilities are reluctant to use even the less-powerful drug.
Science and health observers are heralding the removal of Opana ER as a positive step. Even so, researchers agree the removal is a small step toward the eradication of opioid abuse. Opana ER received U.S. approval in 2006 and in 2012, Endo International changed the drug’s formulation to make it harder to abuse. The FDA approved sales of the new version, which included a hard-to-crack coating. The new coating made the drug harder to inject. Endo wanted to market the new formulation as “an abuse deterrent,” but the FDA refused.
The agency requested the company stop selling Opana ER after reviewing its safety at a hearing this March. The vote to remove the product was 18-8 against keeping it on the market.
Opioid addiction has been a frequent news item lately, as evidence mounts that this country is reaching near-epidemic numbers. Only time will tell whether there will be enough of a national hue and cry to make further opioid removal a reality.
This latest development comes at an interesting time in this nation’s timeline. While tolerance for certain drugs is on the rise, opioid intake is only recently receiving scrutiny. Developments in the next few years will signal the direction we intend to take.