Endo Pulls Opana ER Off the Market

[makita (OP)]

Anyone have any idea whether this affects generic Oxymorphone ER too?  Sounds like it's just the name brand, in which case fuck 'em and good riddance to that toxic bullshit.  But this could spell the beginning of a bad trend for opioid meds, esp since the press and public doesn't really seem to understand the difference between pulling a drug because it causes dependence and pulling a drug because it's been reformulated with toxic crap that hurt people when they try to inject it.  Given the climate I don't see Endo bringing back the old stop signs, even though that would technically solve the problem the FDA is complaining about.  Maybe they will re-reformulate it to be less toxic, but still "abuse deterrant": I wouldn't be surprised if this allowed them to repatent the drug, which would explain their willingness to pull it so easily (it's always about profit). 

Dr McKay is rolling over in his grave.




http://www.medscape.com/viewarticle/882578?nlid=116333_2051&src=WNL_mdplsnews_170707_mscpedit_psyc&uac=242840CT&spon=12&impID=1385122&faf=1

Endo Pharmaceuticals has agreed to remove its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) from the US market, about a month after the US Food and Drug Administration (FDA) asked the company to stop selling the pain medication.

In a statement, the company said it "continues to believe in the safety, efficacy, and favorable benefit-risk profile" of Opana ER when used as intended. "Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market."

As previously reported by Medscape Medical News, the FDA asked Endo Pharmaceuticals to take Opana ER off the market on the basis of a review of postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal administration to injection after the product's reformulation.

Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV infection and hepatitis C virus infection, as well as cases of thrombotic microangiopathy, the FDA said.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a news release in June. "This action will protect the public from further potential for misuse and abuse of this product."

This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse.

The request by the FDA came on the heels of a March meeting of an FDA advisory panel of independent experts who voted 18 to 8 that the benefits of reformulated Opana ER for relief of severe pain no longer outweigh its risks.

Endo Pharmaceuticals said it will work with the FDA to coordinate the "orderly removal" of Opana ER to minimize treatment disruption for patients and allow patients sufficient time to seek guidance from their healthcare provider on other treatment options.

According to the company, net sales of Opana ER were $158.9 million in 2016 and $35.7 million in the first quarter of 2017.

[thetalkingasshole]

Dr. McKay 

F

[Dog Food]

Sounds like they were happy to remove that reformulated opana er, they only took a month. Probably gonna bring out a new formulation that can be sniffed easier but not injected or some shit.  Thatd be fine with me, i got way more out of sniffing them fuckers than i do out of shootin dope since they reformulated em.

I gotta say, those stop signs were my favorite years of my dope career, way better than the oc80s and i still liked em a lil more than the iv dope since 2012 or so.  I just never nodded off dope like i did every time i did them pandas. That chalky taste hittin the inside of your nasal passages.  Mmmmmmm

[dizzle]

How has the reformulated version caused hiv and hep c outbreaks any more than dope or any other needle drug?

[Thoms]

I'm glad they pulled it as hopefully more generics will show up for the people who use opana. I'm sure endo had other reasons besides the fact that people are dying because of the shit it is putting into people's veins. Me myself? I would never shoot a ref. I could never figure out how people did. The ir opana were most likely the best drug I have ever had the pleasure of shooting. I say likely because I didn't have enough to make a good comparison with morphine as that was my favorite drug. I bet a combo of the two would be an amazing thing. The nod of opana and the pins and needles of morphine. Yummy.

[Esoteric Anhydride]

^^ Word, I had the pleasure of a proper IR Opana hook for awhile, $10/10mg -- big fat frothy pink 50mg shots. Probably the best pharmaceutical dope I've ever had, save for Fent and OG Knoll Dilaudid (which doesn't do shit for me anymore, even with stellar doses). Oh and maybe some proper homebake, but that isn't exactly pharmaceutical..

[dillydudeEL14]

I get the ir opana 10s all the time they are my second favorite behind dilaudid. A very close second. I’ve never seen any form of er opana in my 6 or so years of using opana. Never seen exalgo either. One good thing about Florida seems to be that even tho pills are expensive af now at least the pills that are around are good ir pills. And at least for me they are ALWAYS available. Still pricey but always there. Wish I could get opana ir 10s for 10 bucks. I pay triple that.

Oh and it seems from what I’ve read online that the generics are still available. I can’t confirm that though as I’ve never seen one.