In the wake of an HIV outbreak in Indiana last year that health officials believe was triggered by opioid addicts injecting rather than crushing and snorting Opana ER, Irish drugmaker Endo ($ENDP) has withdrawn its application to label the pain med as an "abuse deterrent.”
The company said that following talks with the FDA last week, it decided to withdraw its supplemental NDA that targeted specific abuse deterrent labeling for Opana ER. The move was done without prejudice for re-filing the application, and Endo said it will continue to collect and analyze data on the drug.
"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER," Sue Hall, Ph.D., an executive vice president at Endo, said in a statement. "We believe in the ability of Opana ER to continue making a difference in the lives of appropriate patients and remain committed to safely and effectively addressing the needs of the pain patient community."
The company had hoped its Intac technology, which increases the hardness of the pill using a high molecular weight polymer (polyethylene oxide), would prevent addicts from crushing and snorting the opioid.
Unfortunately, the CDC and local officials found that the hardened reformulation of the drug introduced in 2012 may have made it easier for addicts to inject rather than snort. The intravenous use, and sharing of needles, likely accounted for the uptick in HIV cases in southern Indiana; something regulators warned about in 2013.
An approval of Opana ER as a deterrent to opioid abuse wasn’t included in Endo’s financial forecasts for 2016.
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