The Food and Drug Administration (FDA) announced Friday that it will allow the continued sale of generic forms of the prescription pain drug Opana ER, after the agency found that a new form of the drug was not significantly more successful at preventing abuse.
Opana, which is manufactured by Endo Health Solutions, is an extended-release narcotic. These types of drugs are popular among addicts, who crush the pills in an effort to snort or inject the full dose all at once.
Last month, the FDA blocked the sale of generic versions of Purdue Pharma's OxyContin after the agency ruled that a newer, tamper-resistant version of the pain pills was more effective at deterring abuse. But Endor Health Solutions had no such luck, even after it relaunched Opana ER in 2012 with a new anti-crush design.
Endo argued to the FDA that users were abusing older versions of Opana 80 percent more often than they misused the new painkiller. But, although the FDA said that it would “continue to encourage the development of abuse-deterrent formulations of opioids,” it declined to stop sales of generic Opana versions.
"Reformulated Opana ER can be readily prepared for injection, despite Endo's claim," the FDA said in a statement. "It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods."
Read more at the Wall Street Journal.
For more InsideCounsel coverage of the pharmaceutical industry, see: