Endo pulled the request this month, citing feedback from the US Food and Drug Administration (FDA) and hinting that more data is needed.
Endo spokeswoman, Heather Zoumas Lubeski, confirmed the supplemental new drug application (SNDA) seeking abuse deterrent labelling for Opana ER has been withdrawn.
She told us "The sNDA was originally filed in February 2013. A complete response was received in May 2013. Endo filed a response to the complete response in January 2016."
In a statement Endo said: "We anticipate the generation of additional data and we will seek collaboration with FDA (Food and Drug Administration (FDA) to appropriately advance Opana ER.” The firm decline to provide additional details.
Reformation
Opana ER is an opioid indicated for the management of pain severe enough to require daily, around-the-clock pain treatment and for which alternative treatment options are inadequate.
Initially, Opana ER was formulated with an extended release technology called Timerx that Endo bought along with developer Penwest in 2010. However, in 2012 Endo stopped making the original version citing concerns about its potential for abuse.
At the time it said the decision had been taken “with the intent of helping drive appropriate use of Opana ER, Endo ceased production of the original formulation.”
A year earlier Endo had won FDA approval for a version of Opana ER formulated with a technology called Intac that was developed by Grunenthal.
Intac is a polymer – polyethylene oxide – that makes tablets hard to crush. The reformulated drug was launched in March 2012.
Competition
In addition to reformulating, on September 6, 2012 Endo lobbied the FDA to acknowledge that the old version of Opana ER was discontinued due to its potential for abuse.
It also asked the agency to require that developers of competitor products referencing the original formulation provide data indicating their drugs were also crush resistant.
These requests were rejected in 2013.
When the FDA turned down the sNDA it said while the reformulated Opana ER is better at resisting crushing, it can still be “compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing.”
The agency also raised concerns the reformulated drug could be prepared for injection.
Abuse hurdle
Endo’s efforts to win FDA approval to label Opana ER as “abuse deterrent” have been widely reported. Its decision to withdraw the request does not indicate the formulation technology is not effective according to a Grunenthal spokesman.
“We believe that the properties of Intac add significant to prescription drugs.
He added that: “Grunenthal will continue investing into the advancement of the Intac technology platform.”