Endo's opioid painkiller Opana ER took a hit on Tuesday when an FDA advisory committee decided that the drug’s benefits no longer outweigh its risks. If the agency agrees, it could pull the med or restrict its use in yet another setback for the ailing drugmaker.
By a vote of 18 to 8, experts at a joint FDA committee meeting determined that the opioid pain med’s benefits don’t outweigh its risks. According to Endo, some experts felt that the drug’s benefits are “overshadowed” by “misuse, abuse and diversion.” The FDA isn’t required to follow its agency’s recommendations, but it generally does.
Naturally, Endo sees things differently. The drugmaker “remains confident that the body of evidence established through clinical research demonstrates that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients," Matthew Davis, M.D., SVP of R&D for branded pharmaceuticals at Endo, said in a release.
Opana ER brought in $158 million in sales last year for Endo, a 10% drop from 2015 because of generic competition. Back in August, the drugmaker gave up on its quest to get an “abuse deterrent” label for Opana ER, pulling a supplemental new drug application in order to generate more data.
That followed a controversy in southern Indiana, where authorities found that addicts had been dissolving and injecting the drug, resulting in a spike in HIV transmissions. Regulators warned Endo about that potential for abuse back in 2013.
Introduced in 2012, a new version of the drug featured a coating to deter people from crushing and snorting the med, but ironically that reformulation may have made it easier to prepare for injection.
Some committee members wanted the med to remain on the market with more restrictions, an option RBC Capital Markets analysts figure is most likely.
After Tuesday’s vote, Canaccord Genuity analyst Dewey Steadman said he believes “any potential impact to Endo will be muted given the product’s small contribution to Endo’s top and bottom lines.”
While the committee members voiced a “generally negative” opinion of opioid prescribing in the U.S., they did note the importance of having a number of options available, Steadman said. “We don’t see widespread recalls or withdrawals of opioid products following” the discussion, he said.
Meanwhile, Endo recently announced two rounds of job cuts, one in December eliminating 375 sales reps and staffers, and another in January that claimed 90 corporate and R&D positions. As part of the December cut, Endo won’t promote Opana ER going forward. RBC analysts predict $128 million in sales for the drug this year, a number they expect to fall to $93 million by 2019.