FDA panel opposes pure hydrocodone painkiller

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nervousone

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WASHINGTON (AP) — Government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

The Food and Drug Administration's panel of pain specialists voted 11-2 with one abstention against Zohydro for moderate to severe chronic pain. The drug was developed as a long-acting pain reliever by San Diego-based Zogenix Inc.

The FDA is not required to follow the group's recommendation, though it often does so.

The panelists acknowledged that the pill would likely reduce pain, but worried it would exacerbate the national epidemic of prescription painkiller abuse.

"I think the sponsor fulfilled the expectations of FDA, however I think the entire class is problematic in terms of abuse and safety issues," said professor James Ware of the Harvard School of Public Health.

If approved, Zohydro would be the first pure hydrocodone medication available in the U.S. Currently available products combine the drug with lower-grade painkillers such as acetaminophen.

Hydrocodone is prescribed to treat pain from injuries, surgery, arthritis, migraines and a variety of other ailments.

Hydrocodone-containing pills consistently rank as the first or second most-abused medicines in the U.S., according to the Drug Enforcement Administration.

The drug belongs to a family of medicines known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, methadone and hydromorphone.

Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. Several panelists said the risks of fatal overdose with opioids swayed their vote against Zohydro.

"I have traveled around the country and I have seen the repercussions of opioids — they are a threat to public health," said consumer panelist, Rodney Mullins, of the Health Promotion and Advisory Council.

In 2011, the Centers for Disease Control estimated 14,800 deaths were related to opioids.

Zogenix has touted the benefits of its long-lasting pill, which only needs to be taken once every 12 hours, compared with every four to six hours for combination drugs like Vicodin. The company also notes that patients taking pure hydrocodone would not be at risk for acetaminophen-related liver side effects.

Panel Chairman Randall Flick of the Mayo Clinic abstained from voting, but suggested Zogenix might reformulate the drug to make it more difficult to abuse. Drug abusers often crush or dissolve pills in liquid to unlock their extended release mechanism and get an intense high.

"It is my view that tamper-resistant formulations are likely to reduce the incidence of morbidity and mortality associated with this class of drugs," Flick said.

In recent years the FDA has begun prodding drugmakers to develop more sophisticated pain relievers that are harder to abuse, but such measures are not a requirement.

Zogenix said it would focus sales on 15% of the 330,000 U.S. health professionals who prescribe high-strength prescription painkillers. The company said it would to monitor prescribing patterns and visit physicians who appear to be writing more prescriptions than normal.

Shares of San Diego-based Zogenix were halted ahead of the meeting and last traded at $2.36.
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http://www.usatoday.com/story/news/nation/2012/12/07/pure-hydrocodone-painkiller/1755005/
 
looks like some lobbyist fucked up somewhere down the line, this wouldve been a very popular pill thats for true
 
No, it should've gone through! Patients shouldn't forced to consume all of that Acetaminophen!

Damn. Sucks for my friends dad and all of the other legitimate pain patients that don't want to damage their livers.
 
This is sad news. If the only purpose of APAP is as an abuse deterrent, then the FDA has blood on its hands that can't be ignored.
 
Thanks FDA. Thats professional. I dont get it. Hydrocodone is a great painkiller. The U.S. needs better options for addiction and pain related opiate or opioid treatment.



BTW why the Fuck would you reformulate an XR mechanism for the Hydrocodone when that shits already available at compounding pharmacies and shit. Stupid. People are gonna abuse anything if their desperate--why put a risk for those who chose to do it. Just like that Opana shit. Where did the common sense go. Does anyone have any these days?
 
i was reading about alcohol prohibition in the U.S. and about how the gov't started adding all sorts of fucked up shit to alcohol to deter people from drinking it which ended up in 10,000 people dying. When you think about how that happened, this is not much of a surprise. Same stupid shit, guess no one learned anything.
 
i think a regular patient using hydrocodone would at some point prefer not to risk any liver damage even if only taking the recommended 3g/day or whatever it is now. For many patients, they won't know any better than to take what a Dr. prescribes them and not even consider a CWE.
 
RobotRipping said:
i think a regular patient using hydrocodone would at some point prefer not to risk any liver damage even if only taking the recommended 3g/day or whatever it is now. For many patients, they won't know any better than to take what a Dr. prescribes them and not even consider a CWE.
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Then they should sue their doctor if they are damaging their liver, as the doctor should know better than to prescribe such a high dosage of APAP.

I also tend not to feel sorry for people who explicitly trust their doctor and never question them.
 
I can tell you first hand that doctors are writing more norco than vicodin scripts. I have to verify the APAP dosage all all vicodin scripts since they have a new version with 300 mg APAP. Unfortunately, most doctors aren't aware of it and pharmacies aren't stocking it due to cost and lack of popularity.
 
I was prescribed hydrocodone (no hyphen on the script, previous poster) 10/325 for two years. Sometimes the pharmacy label would say hydrocodone and a few times it was marked Norco. So essentially it's the same drug, just different manufacturer. Six of one - half dozen of the other.

I feel that's shitty that these "Government Health Experts" want to stop the production of apap-free vicodin. People with chronic pain shouldn't have to take all that tylenol. I mean they do make vicoprofen but some people can't tolerate n-saids either.
 
A serious discussion needs to be had about reintroducing heroin into the pharmacopia. Heroin is the Rolls Royce of painkillers I think.
 
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