Endo is putting the brakes on its bid to label its opioid pain med Opana ER "abuse deterrent."
On Friday, the Dublin drugmaker said it had decided to withdraw its supplemental new drug application related to the labeling, and it now plans to drum up and analyze more data surrounding the med.
"We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER," Sue Hall, the company’s R&D head, said in a statement.
The move follows controversy surrounding the med and the role it played in last year’s HIV outbreak in southern Indiana. As the CDC and local officials determined, the outbreak resulted from addicts dissolving and injecting Opana ER--a possibility regulators warned Endo about in May of 2013.
While the new version of the drug, introduced in 2012, boasted special coating that supposedly made it more difficult to crush for snorting, the reformulation may have made the med easier to prepare for injection, the FDA found.
Endo isn’t the only company that’s raced to add abuse-deterrent properties to its opioid therapies--and it’s not the only company that’s run into problems marketing those properties. In June, the FDA dismissed an advisory committee recommendation and shot down an opioid pain candidate from KemPharm; while the panel had voted in favor of approval, they hadn’t deemed the prospect worthy of an “abuse deterrent” label.
Meanwhile, though, thanks to generic competition and an opioid market slowdown, Endo isn’t counting on sales contributions from Opana ER. Barclays analysts were also unimpressed by fellow branded meds Belbuca and Xiaflex, though, which didn’t put up big growth numbers to fill the void.
“We feel that the long-term growth profile is still in question,” they wrote in a note to clients.
- read the release
Endo keeps up its Valeant act with asset-sale talks
FDA overrides adcomm, shoots down KemPharm’s opioid
Abuse of Endo's second-generation Opana ER formulation implicated in Indiana HIV epidemic