Chronic Pain — 21 December 2012

opanaBy Richard Lenti

Generic versions of the widely abused painkiller Opana are set to hit the U.S. market at the start of the New Year after drug maker Endo Health Solutions Inc. (NASDAQ: ENDP) lost its bid to halt their release.

This week federal Judge Reggie B. Walton, of the U.S. District Court for the District of Columbia, dismissed a lawsuit by Endo against the Food and Drug Administration. Endo claimed the FDA failed to meet its legal obligation to determine whether the original formulation of Opana ER was withdrawn from the market for safety reasons.

Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone. Endo began selling Opana ER in 2006 and it quickly became one of the nation’s most widely abused opioid painkillers.

Endo launched a new version of Opana in March that is tamper resistant. It claims in court filings the original formulation is unsafe because the pills can be crushed and snorted by drug abusers. Endo was seeking a preliminary injunction to have the FDA suspend approval of the generic Opana, which is based on the original formula.

But the judge ruled against Endo, saying that he believes the FDA had not unduly delayed making a determination on the matter.

In its argument before the court, the FDA said it was not convinced that Endo was concerned with the health of drug abusers, since Endo had not recalled its original formulation of Opana ER. The FDA said the company’s insistence that the ganecy officially note the old version was withdrawn for safety reasons by December 31 was more a tactic to delay another generic company from entering the market.

“The December 31 deadline reflects only Endo’s commercial concern that, as a result of a settlement agreement it made with another manufacturer, it will face additional generic competition beginning January 1, 2013,” FDA attorneys wrote.

The judge’s ruling allows for a generic Opana that is not tamper resistant to enter the market on January 2, 2013. Impax Laboratories Inc. (NASDAQ: IPXL) and Actavis South Atlantic LLC are among producers of the generic Opana ER.

“We are extremely disappointed,” said Dave Holveck, president and chief executive officer of Endo. “Despite the fact that the generic product will not be therapeutically equivalent to the crush resistant formulation, the launch of a generic non-crush-resistant version of Opana ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone.”

This battle over the release of generic versions of older opioid painkillers is similar to one waged last month when the Canadian Health Minister rejected pleas to delay approval of a generic form of OxyContin because it would trigger a new round of abuse and addiction.

Opana ER is prescribed for the relief of moderate to severe pain. A Schedule II controlled substance, it is physically addictive with side effects that include shallow breathing, slow heartbeat and seizures.


About Author

Richard Lenti

Richard Lenti has worked as a news writer for the last 20 years at various television stations in Los Angeles. He is a Golden Mike winner and a graduate of California State University, Fresno. With roots in print journalism, Richard is excited to be “published” once again; having people read his work as opposed to having it read to them. As a freelance writer his work has appeared in the Easy Reader, L.A. Jazz Scene, Irrigation and Green Industry, and the KCAL 9 Online website.

(6) Readers Comments

  1. I read this article and I am interested in further studies. I personally have been a addict since I was 10 years old. Just found this article by looking through this website dedicated to friend I went to school with in Edina Minnesota. I am currently on a high dose and daily dose of suboxone tablets. I take 4 a aday how ever as an addict I find many ways to mix and abuse it. I was overdosed 5 times and intensive care this last time just a year ago. in an addicts mind it is so hard to turn off that “hurt” that we have inside. Just a quick note saw your article. love to hear more as you may find and report on.

    Jeff, MN

  2. I called CVS and asked about the generic Opana ER – they said they have the generic but it’s not made in the ER formula so I called Impax and yes, they DO make a generic form of Opana ER but it is not called Opana – it is called Oxymorphone ER and the product number the pharmacies need to order from distributors is:
    0115-1234-01 for the ER 40. I hope this helps – I am going to call my pharmacy and give them this information.
    Yes, it is obvious that Endo only cares about profits – and I’ve read posts that make me cringe in that people ARE crushing the TRF and injecting this dangerous gel and they are dying! I had reflux surgery last March 2012 and it was at the same time that ENDO brought out this TRF of Opana ER – last week I had to have tests to find out why I was having such bad stomach problems and I was told I have two ulcers! I firmly believe it is from the GLUE-LIKE SUBSTANCE that I am forced to put into my body because of my pain!! I will be asking my doctor to change my prescrition to the generic and I’ll be willing to bet my ulcers will clear up!

  3. Making Opana ER crush resistant did not keep people from abusing. If anything its much mush worse! People who abuse this drug are now injecting the pill! You tell me which is more dangerous?! I take mine orally and am insulted that teens and adults would stick a needle in their arm to get the full effect of a time released medication. I do believe it was safer, even for abusers to have the old formulation. A rise in profits is definitely why Endo is against it. They are very expensive and there have been no generics thus far. Therefore, of course, they will lose a lot of business but the pharmacies are still not aware of the generic. Someone needs to give a site wher they can look or a number they may call to be able to verify this. I go to cvs and one said they could get it and another said theres no such thing. They all need to be informed.

  4. Martin, don’t you think Endo has the right to try to recoup their investment? Do you think their employees work for free or something? Get a clue and stop crying about a company trying to make some profit…that is what they are supposed to do!

  5. Endo saw their patent expiring in 2012 and decided to make a new patent to last until 2023 on their new crush resistant formula in an effort to be the sole manufacturer of the pill, and they obviously were not concerned about the abuse by the users. This is an obvious attempt to secure more profits and prohibit others from selling “their” medication. They shot themselves in the foot because now everyone will move to the less expensive generics in lieu of the brand name tamper resistant formula. I will tell you from personal experience that the new formulation from Endo does not work as effectively as the old formulation. They are not concerned about their users and just want more money. I’m glad a judge could clearly see this and I hope Endo suffers greatly from their greed. People can still abuse the instant release formula, so making the ER formula crush resistant at the expense or the patients is a stupid, pointless move. Not to mention, drug abusers can still circumvent the tamper resistant formula. Where there is a will, there is a way. Too bad Endo…please learn a lesson from this.

  6. If Endo truly cared about the abuse potential and reducing addiction, they would make their new formulation available to the generic manufacturers and forego their patent on this new technology. By not doing so, they tip their hand and show that it really is all about “commercial concerns” and profits.