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FDA OKs Zohydro, 1st Hydrocodone-Only Painkiller

Fire&Water

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Jun 8, 2011
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WASHINGTON -- The FDA has approved Zohydro ER (hydrocodone bitartrate extended release tablets) for long-term treatment of refractory severe pain.

Zohydro, a Schedule II drug, is the first single-entity hydrocodone product approved by the FDA. Other hydrocodone opioids are typically combined with a non-opioid analgesic such as acetaminophen.

The drug is intended for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate, the agency noted.

"Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain," according to the FDA.

The drug is not indicated for "as-needed" treatment.

story continues: http://www.medpagetoday.com/PainManagement/PainManagement/42493

Right after "Zohydro" was passed for approval today, FDA wants to re-schedule Hydrocodone from schedule III to schedule II.
 
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I've had two different doctors prescribe 10-40 mg of the original Oxycontin and they (and myself) wondered why I wasnt getting any pain relief until I discovered they were passing all the way to my colon w/o dissolving...

Makes you wonder how many people take the new (OP's) 80 mg. and get barely any pain relief, but think its normal ?
 
Hmm, interesting. I wondered when something like this would come out. Im sure ppl will be snorting this shit up, whats the potential dangerous to injection besides the whole pill issue? Histamine release? I know ive read the dangerous just cant remember. If i had a bunch of free ones id take like ten 50s and see if it didn anything. I always kinda liked hydrocodone.
 
I've had two different doctors prescribe 10-40 mg of the original Oxycontin and they (and myself) wondered why I wasnt getting any pain relief until I discovered they were passing all the way to my colon w/o dissolving...

Makes you wonder how many people take the new (OP's) 80 mg. and get barely any pain relief, but think its normal ?

^ sad to think people are suffering because addicts use drugs. Everyone should stand up together on this issue to keep IR meds available to those who need them the most.
 
I'm sure there will be a non ER version available too, but yeah schedule II all the way.
 
hmm looks like the controlled release technology is called SODAS. lol. this is the same tech used for focalin, the er methylphenidate and for avinza the newish er morphine. never had either of these before.

the tech uses tiny orbs that contain a drug surrounded by layers of control release polymers. It sounds like these could be cut open and crushed into a powder similar to the controlled release adderall with the tiny orbs inside. wonder if they will put something in there to make the mixture turn to gel or something when mixed with water to make snorting and IVin difficult. anyone who understands these systems better wanna chime in and lets us know what the deals is with these.

frankly i hope they wont be super easily abuse able. now before you throw your virtual rotten fruit and vegetables my way hear me out. hydrocodone has such a bad reputation IMO because its mixed with tylenol so it damages the liver if you take too much, if you mix with alcohol or other meds, or if you just take it for a long time. for me personally the hydrocodone mixtures currently available make me so nauseous that taking more than one or two vicodin is almost impossible unless i do a CWE and that to me defeats the purpose of using it as a medication when i need it for legit pain.

It actually made my abuse my scripts when i got em cause i couldnt take them and function normally. if i needed to go to school or work i would be too nauseous to do that. the only way to mediate this was to eat a large meal right before dosing, which is not always possible especially since they are indicated for dosing every 4-6 hrs. and for anyone who is a large person like me or naturally opiate tolerant it is really ever 2 hrs or less. this stuff could be exactly what people like me need for moderate pain.

this stuff could actually be safer even if abused cause of the lack of tylenol. most deaths from vicodin and related formulations are from the tylenol and people combining alcohol with it.
 
huh, the impossible finally happened

now ive never needed to know this, but now i must inquire, could one shoot pure hydrocodone and get good effects? or is it like codeine where that doesnt work, and it needs to pass through the liver and turned into hydromorphone (morph for codeine) first?? obviously would not shoot the pills discussed here, but you know...
 
I'm sure there will be a non ER version available too, but yeah schedule II all the way.

Hydrocodone has always been Schedule II. It's only Schedule III if its in combination products (Vicodin, Norco, Lortab, etc). Since Zohydro is just hydrocodone, it's placed in Schedule II. So nothing is changing there.
 
Hydrocodone has always been Schedule II. It's only Schedule III if its in combination products (Vicodin, Norco, Lortab, etc). Since Zohydro is just hydrocodone, it's placed in Schedule II. So nothing is changing there.

Thats odd...a buncha years ago I was able to get a compounded form of hydrocodone (containing no OTC anti-inflams') phoned into a pharmacy from a dental surgeon.
??
 
I've had two different doctors prescribe 10-40 mg of the original Oxycontin and they (and myself) wondered why I wasnt getting any pain relief until I discovered they were passing all the way to my colon w/o dissolving...

Makes you wonder how many people take the new (OP's) 80 mg. and get barely any pain relief, but think its normal ?
did I read this right F&W you didn't get relief from the originals? I also know many opiate addicts that like hydrocodone the best and think it causes the best euphoria for them.
 
did I read this right F&edeW you didn't get relief from the originals? I also know many opiate addicts that like hydrocodone the best and think it causes the best euphoria for them.

No, its not that...no form of XR opioids will break down or dissolve by the time they reach my small intestines.
They might with the aid of something acidic etc...but F that.

Dont need euphoria, need pain relief.
 
The coincidence of these events is such an example of market manipulation by the FDA! By raising Vicodin and Lortab to schedule II, they've giftwrapped a much bigger market for Zohydro's maker.

I hope the bribes were generous.
 
The coincidence of these events is such an example of market manipulation by the FDA! By raising Vicodin and Lortab to schedule II, they've giftwrapped a much bigger market for Zohydro's maker.

I hope the bribes were generous.

Oh Yeah...this shoulda' been the title of the thread...
 
This new drug is gonna be very expensive if you dont have insurance. Even if you do have insurance it will probably still be a lot more expensive than the existing hydrocodone formulations. As 23536 said this seems awfully suspicious that these two actions by the FDA occurred in the same week.

Now Percocet, Lortab, Vicodin, Oxycontin, and now Zohydro are all the same schedule do you guys think that it will be a toss up as to what a doctor will prescribe for pain or do you think its gonna be scripts for ibuprofen instead of an opiate?

I personally have gotten furious when a doctor prescribed the 800 MG ibuprofen formulation for pain. Its insulting, you dont go to the doctor and pay a bunch of damn money to be told "you are in pain but its nothing serious here pay 5x the cost for the same exact fucking thing you could get at the store WITH NO FUCK SCRIPT."

When i was in college i had three different doctors at the Student Health center. One was great and would always give me either codeine tablets, hydrocodone tablets or codeine syrup for the problems i had, usually just strep or bad respiratory infection. Another doctor would prescribe bullshit like dextromethorphan/guafinisne tablets and ibuprofen for the same respiratory illness.
The third doctor gave me codeine tablets but refused to give me a month of sleeping pills. I got very sick at that time cause i was having serious trouble sleeping due to stress from school. He gave me a like 5 pills of ambien and wouldn't prescribe more just cause he was also giving me codeine. His logic was that codeine and ambien were not good to take together, but even after i explained that i understood that and would not take them together he still refused to prescribe more. Fucking doctors, sometimes they think patients are all morons and can not be trusted with anything that maybe could possibly be used to get a person high.
 
I heard the FDA shot this down months ago? Well, who gives a damn. Time to get me some! Is this the same form of hydrocodone (hydrocodone polistyrex) that they put in Tussionex?
 
^
With 2 spoons or a lighter and cigarette pack cellophane?
 
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