Governor's Attempt to Ban Zohydro Overturned

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297point1

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The Governor of Massachusetts attempted to ban the sale of Zohydro within the state by declaring a public health emergency, but his order was overturned by a federal judge.

http://www.boston.com/news/local/ma...-painkiller/9kaVOLjUnHitIsXzn1irMK/story.html

Of note:
The state argued that Zohydro would ‘‘exacerbate a severe public health crisis’’ because the narcotic can be easily crushed, then snorted or injected to create an immediate and potentially lethal high.

In her decision, the judge noted the FDA’s approval of the drug in October and said federal law pre-empts Patrick’s emergency order. ‘‘When the Commonwealth interposed its own conclusion about Zohydro ER’s safety and effectiveness by virtue of the ... emergency order, did it obstruct FDA’s Congressionally-given charge? I conclude that it did,’’ Zobel wrote. She said allowing the ban would ‘‘undermine the FDA’s ability to make drugs available to promote and protect the public health.’’ She said the governor’s suggestion that the ban might be lifted if Zogenix created a non-crushable ‘‘abuse-resistant’’ version of the prescription medication would force Zogenix to return to the FDA to seek approval for a drug different from the one that the FDA has already deemed safe.

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Well in order to get Zohydro from a CVS/pharmacy, there is a lengthy process. We can't even have the drug on hand. It has to be ordered only after a hardcopy Rx is given to us. Then it has to go through some CVS validation where we send all the "clinical" info to some corporate thing and they send us back with a yes or no answer as to if we can fill it or not. Then we take care of any PA issues and all, and only then are we allowed to order it.

Honestly, F*CK these dumba** drug companies. What a waste of a drug.

Anyways, anyone heard of this new extended release oxy/apap 7.5/235? Dosing is BID. Apparently for breakthrough pain it is recommended to give ibuprofen. LMAO. Seriously? How desperate are these companies?
 
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West Virginia is getting nervous about Zohydro too...
http://www.bdtonline.com/local/x749...th-illness-statistics-grim-in-Mercer-McDowell

The quote of the month: "It's oxycodone on oxycodone."

Except that it isn't. It's less potent than oxycodone. There is nothing a 50mg Zohydro can do that a couple of instant release oxycodone 30s can't do better. Such idiocy.

Though Southern WV is pretty much ground zero for opioid overdose and death, so I can see their concern.
 
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I agree with Mike. This is a silly hand wringing display. How many other narcotics come in IM form or easy to abuse CR forms? If this product is so scary, simply don't stock/order it just give them Ms-contin, the old opana ER, fentanyl or any of the other safe ER products
 
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More court action on this issue: the federal judge ruled that Massachusetts' most recent attempt to require a letter of medical necessity before Zohydro could be prescribed was an illegal curb on a federally approved drug.
http://online.wsj.com/articles/zogenix-has-partial-victory-in-zohydro-court-battle-1404845974

This begs a question: If Massachusetts isn't being allowed to impose requirements above/beyond what the FDA has established, how can any state impose their own requirements? I frequently read on SDN about states assigning C-IV or C-V designations onto products that aren't FDA labeled as such. Will manufacturers begin to challenge these state-specific designations? (Or have the existing state-specific designations all been for generic products that brand manufacturers don't care about?)
 
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Why doesn't MA just schedule it as a CI? Seems like an easy fix to me...
 
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I wonder when the drug companies will market an opioid/benzo combination. I don't think zohydro will sell very well.
Compounding pharmacies already make hydrocodone capsules for legit patients who can not tolerate the acetaminophen/hepatotoxicity issues. And the dope heads are already using cold water extraction to purify the hydrocodone from the acetaminophen.
 
I still don't understand why Zohydro is more of a problem than Roxicodone? Do people think that being in more than one pill (2-3 tabs of Oxy 30mg) has any deterrent effect on people intent on abusing?


I think some of the disgruntlement is how this drug got on the market. It DOES not provide any advantage over other long acting opioids. Unless this is going to cost less than OxyContin there is no reason it should be on the market.
 
I think some of the disgruntlement is how this drug got on the market. It DOES not provide any advantage over other long acting opioids. Unless this is going to cost less than OxyContin there is no reason it should be on the market.

Well, one could say the same about 75% of new drug approvals, really how many HMGCo-A inhibitors does 1 country need?
The point isn't whether any patient should actually waste their money on this, the point is its silly for some state governments acting like this is some horrible drug, when there is no reason to think addicts would prefer this drug, or have any easier access to it, then to a different CII drug such as oxycodone,.
 
I think some of the disgruntlement is how this drug got on the market. It DOES not provide any advantage over other long acting opioids. Unless this is going to cost less than OxyContin there is no reason it should be on the market.

Actually it does provide one good benefit. It provides another option for Opiate Rotation. Previously Hydrocodone was not an option for most pain patients, because the required daily dose meant way too much acetaminophen. Zohydro allows for a new option in treating severe chronic pain. Before we did MS Contin to Oxycontin and back. Opana ER and Exalgo are good options for those where alternation doesn't provide as much benefit. This gives us one more.
 
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