FDA wants Opana ER pulled off the market

[ScoobySnax30]

http://www.cnn.com/2017/06/08/health/fda-opioid-opana-er-bn/index.html


(CNN)The US Food and Drug Administration said Thursday that drugmaker Endo Pharmaceuticals must remove its powerful opioid painkiller Opana ER from the market. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse."

"We are facing an opioid epidemic -- a public health crisis -- and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA Commissioner Dr. Scott Gottlieb said. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."

The drug is about twice as powerful as OxyContin, another often abused opioid. Opana ER, oxymorphone hydrochloride, is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternatives aren't strong enough, according to the manufacturer's website. The FDA approved it for this use in 2006.
"My comment is 'wow,' " said Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. "This is pretty exciting. This is big news."
Though it is a "good sign" for the fight against opioid abuse, he said, "Opana is not the only one that needs to come off the market."
Endo had tried to make it harder for addicts to use Opana ER by making it with a coating that made it hard to crush. The medication is intended to release over time, but addicts had been crushing it to get a massive high all at once.

 

[Jekyl Anhydride]

http://www.cnn.com/2017/06/08/health/fda-opioid-opana-er-bn/index.html
"My comment is 'wow,' " said Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University (Boston). "This is pretty exciting. This is big news."
Though it is a "good sign" for the fight against opioid abuse, he said, "Opana is not the only one that needs to come off the market."
Endo had tried to make it harder for addicts to use Opana ER by making it with a coating that made it hard to crush. The medication is intended to release over time, but addicts had been crushing it to get a massive high all at once.

Dam... This is setting a precedent where the FDA (and probably the DEA next) can override the pharmacotherapy decision of a Doctor and this guy is "excited" and wants to go after more ?!? This is as bad as mandatory minimums in a court of law.

Opana ER is loaded with polyethylene oxides, the coating is just hypromellose. It is almost impossible to crush and the people that attempt to defeat the release mechanism usually have poor results. The opana thread going back to 08' is a perfect example of how the abuse deterrent is fairly effective. The generics are a different story, but still in this opioid hysteria Docs aren't handing out Opana without the patient having a substantial injury or malady. I'd bet money the Roxies are next in line for discontinuation to uphold "public safety".

 

[LucidSDreamr]

^ that guy is heavily lobbied by the rehab industry which wants the only option whatsoever for any opioid on the planet to exist to be suboxone, available ONLY through a rehab.

...this is the goal of Dr. Kolondy. His goal is to fully eradicate opioids and have all pain patients or heroin addicts all be on suboxone, even cancer patients that are terminal.

He has an organiziation called PROP backed by rehab industry that does heavily lobbying on the FDA and CDC with the goal of eradicating opioids. The website is full of total lies and rigged statistics.

....the only thing that gives me confort is that the manufacturers of opioids have way bigger money and lobbying power than that piece of shit, which I hope someone permanently cripples and smashes his spine into gravel then deprives him of opioids while he lays in bed shitting himself for the rest of his prick life.


pain advocacy groups are pretty weak in their lobbying and publicity power, they are also all afraid to align themselves with seeming like they promote opiate use.

There is a serious lack of pain patient advocacy.

 

[Felonious Monk]

This is one case where I can't help but agree with the FDA. Fuck Endo Pharmaceuticals. Changed the formula of Opana just so they could keep patent protection, while fucking over generic makers and patients at the same time. Then it turns out their new formula is super fucked and has helped lead to HIV outbreaks in Indiana and blood illnesses in West Virginia.

This is not a case of the FDA fucking with patients. This is one case of them protecting patients from pharmaceutical company greed, regardless of how Kolodny wants to try to spin it.


I do agree with you that there is a lack of pain patient advocacy though. Check out the U.S. Pain Foundation though, they're an organization doing just that.

 

[Jekyl Anhydride]

^

Kentucky, for instance, saw a spike in Opana overdose deaths in 2011 according to the executive director of the Kentucky Office for Drug Control Policy. But the issue seems resolved since the drug became tamper-resistant.
There’s nothing specific about this drug to link it to HIV according to expert opinion. Sharing needles, regardless of the substance, creates the risk of contracting whatever disease the previous user had.

Indiana:
While some are sure that the lift on the needle exchange ban would help the issue, it seems that the progressive idea to save lives is being suffocated by local law enforcement.
Indiana Governor Mike Pence declared a state of emergency at the end of March after the CDC persuaded Pence to lift the syringe and needle ban, extending it on April 20 for another 30 days to combat the growing HIV outbreak.

Addicts and community activists have reported to having needles and syringes confiscated by police. It seems law enforcement officials in Indiana remain committed to enforcing the anti-paraphernalia laws in spite of the legislation.
This is extremely detrimental to the cause. Without access to clean needles, addicts are sharing needles up to a staggering 300 times according to Brittany Combs who is a public health nurse for Scott County. The process of getting clean needles to the community is further disrupted by red tape and a fear of the police.

palmpartners.com/category/opana-drug-abuse/


I hate the greedy bastards at Endo too but I can't place all the blame of an outbreak on Opana with the 1950's backwards republican approach to Harm Reduction going on in the affected areas. Secondly to deny a million pain patients an efficacious medicine because a handful of counties in a couple states are having or were having problems seems ridiculous.

 

[Felonious Monk]

They're literally only removing Endo-brand Opana from the market (not Oxymorphone in general, not even generic Oxymorphone ER), which is the one that everyone dislikes to my understanding. There are plenty of other articles I've read which identify Opana as a problem outside of any recreational issues. The equivalent would be removing the OP OxyContin that everyone hates from the market, but keeping the OC formula and keeping Oxy IR. It's seriously not a bad thing at all, and only benefits patients, as it forces Endo to create a new ER formula that is more effective.

 

[Jekyl Anhydride]

I was under the impression that all A/B bio-equivalent generics would be discontinued under an umbrella ban of OxyM itself. Removing only Endo's is nothing more than symbolic. Okay, I'm on board now. F- Endo.