While the federal government claims to be scheming up a master plan to combat the opioid epidemic currently turning the United States population into a junkie nation, its leading health agency is allowing Big Pharma to capitalize on the illusion of safe painkillers.
It was revealed earlier this week that the U.S. Food and Drug Administration (FDA) has approved Egalet Corp’s new time-release opioid, known as Arymo ER and will permit the company to market the drug as an abuse proof medication because it cannot be dissolved and injected. However, the FDA stopped short of giving the company the green light to market its latest concoction as a deterrent for abuse with respect to those people who might chew or snort the drug.
Company officials say the goal of this medication is to provide people with a safer option when it comes to the use of painkillers.
“With the majority of ER opioids in easy to abuse forms, it is important that health-care professionals have additional treatment options,” Egalet president and CEO Robert Radie said in a statement. “Arymo ER has physical and chemical properties expected to make abuse by injection difficult, which is important, given it is the most common non-oral route of morphine abuse and the most dangerous.”
Interestingly, it was the label for this extended-release painkiller that got investment community itching this week to get it on the action. Once it was made known that Arymo ER would be marketed as a drug that “deters abuse,” shares for its stock skyrocketed by nearly 30 percent. It was only after the FDA announced that it would not permit the drug company to promote its new painkiller as completely safe from abuse that shares dropped by around five percent.
But Egalet Corp is not likely to stop pressuring the FDA to deem its medication completely safe from abuse. Reports indicate the pharmaceutical company will have an opportunity in the fall of 2018 to secure this claim after a competing patent expires.
Ultimately, Egalet officials want the Arymo ER label to claim the drug cannot be chewed or snorted by the user in order to obtain a more intense high. The company is expected to continue pushing forward with additional clinical trials that may help it achieve its desired status of a totally abuse proof alternative to pain management drugs.
The FDA also recently approved another “abuse-deterrent” opioid medication called Troxyca ER for Pfizer Inc. It did so even after an advisory panel for the agency expressed concerns about the drug’s ability to curtail abuse.
It seems the focus on limiting abuse is now the federal government’s answer to the opioid epidemic. The FDA certainly has not ceased to provide large pharmaceutical companies with the opportunity to capitalize on addiction in America—this despite the fact that federal statistics show that 78 people die everyday from overdoses to these types of medications.
Meanwhile, marijuana, which has been shown to actually curb opioid abuse rates, remains illegal under federal law.
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