Skip to Main Content

In the end, the executive team at Endo International blinked.

The drug maker has voluntarily agreed to withdraw its Opana ER opioid painkiller in response to an unusual request last month from the Food and Drug Administration over concerns the pill is too easily abused.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

  • There’s an assumption out there that there is a “line” that would never be crossed, i.e. that the proverbial suburban soccer mom on dependent on her daily doses of “mother’s little helper” would never resort to sticking a needle in her arm to shoot smack if she ran out of oxy’s. Experience has proven this to be untrue, and thus yanking more pills from the market will do nothing to stem the opiate epidemic and only accelerate the crossing of that “line” by more and more addicts.

  • oh, and there’s a factual mistake in the article, and a nuance to add.
    for some reason, apparently the reformulation– which is super hard and difficult to grind for inhalation– is easier to turn into a form that is easily injected than the original. so the point that Opana ER (as reformulated) was easy to crush to snort is not correct. the ORIGINAL, as with all non-reformulated opioids (which means every single version of short-acting opioids that have all been generic for many years) ARE easily crushed. And still are.
    The reformulation, if FDA had agreed it made tampering for abuse significantly more difficult, would have created a new patent for Opana ER. But FDA said it didn’t (noting the injection tampering issue). So Opana ER lost its patent several years ago, allowing generic versions to come to market. Before losing patent protection, Opana ER was selling north of $500mm a year. So it wasn’t a BIG seller, but not insignificant either.

  • what about the generics of Opana ER? They are of the old formulation I believe, which was undoubtedly easy to tamper with.
    It would be ironic if the brand, which invested in reformulation to try to make tampering more difficult, were removed while generics of the original formulation remained available.
    Endo makes generics of many drugs as well as having patented brands. Wonder if they will be/already are manufacturing generic versions of Opana ER in the old formulation. That would be ironic.

Comments are closed.