Endo ditches pursuit of abuse-deterrence for Opana
- After discussions with the U.S. Food and Drug Administration, Endo Pharmaceuticals has chosen not to pursue a supplemental New Drug Application (sNDA) for its painkiller Opana ER.
- The sNDA, had it been approved, would have given Opana ER an abuse-deterrence claim.
- Endo will continue to study the abuse-deterrence qualities of the drug and hopes to seek the label in the future, but controversy surrounding opioid abuse has drawn scrutiny on abuse-deterrence claims.
Endo is pulling its sNDA with the FDA after discussions with the agency. While the company didn't disclose the comments from the FDA, it's likely that representatives said the application was not approvable with the data Endo currently has.
The specialty pharma intends to continue its epidemiological studies of abuse deterrence in hopes of filing the sNDA some time again in the future.
"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER," said Sue Hall, Endo's CSO and global head of R&D and quality. "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.”
Opana ER is an opioid pain medication meant for patients with severe pain who need constant treatment. The drug brought in about $38 million during the second quarter and accounted for just under 15% of Endo's revenues.
Yet, the drug has been facing increased competition from generics. An abuse-deterrence claim would go a long way in distinguishing the drug from the slew of low-priced pain medications available.
Abuse-deterrence has become a hot button issue, however, as the number of people abusing prescription pain medications has increased dramatically. Opana ER was mired in controversy last year when it became apparent an outbreak of HIV was spread when recreational drug users were dissolving and injecting the drug.
When the version of the drug was approved in 2012, regulators warned that the coating on the pill which made it harder to crush also made the drug susceptible to abuse by injection.
- Endo Statement
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