FDA approves more powerful, pure hydrocodone drug

Patient safety advocates quick to criticize the approval of Zohydro
Associated Press
Oct 26, 2013

The Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely-abused prescription painkiller.

The agency said Friday it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be treated with other drugs.

Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis and migraines. The new drug from Zogenix is the first pure hydrocodone drug approved in the U.S.

The approval came as a surprise since the agency's own panel of outside advisers gave the drug an overwhelmingly negative review last year. The panel of pain specialists voted 11-2, with one abstention, against approving the drug, questioning the need for a new form of one of most widely-abused prescription drugs in U.S.

Zohydro's approval was quickly criticized by patient safety advocates who had urged the FDA to reject the drug at the public panel last December.

"We're just going to kill more kids and then the FDA is going to come back and say, 'oh, we made a mistake,'" said Avi Israel of Buffalo, N.Y. Israel's son Michael committed suicide in 2011 while struggling with painkiller addiction. Israel is the founder of a group called, Save the Michaels of the World, which aims to combat painkiller abuse in young people.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. Hydrocodone also consistently ranks among 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. Others include morphine, heroin, oxycodone, codeine and methadone.

Friday's news was also blasted by lawmakers on Capitol Hill who have been trying to rein in prescription drug abuse in their home states.

Rep. Bill Keating, D-Mass., said the FDA should have required the drug to contain anti-abuse design features that would make it harder for users to crush the pills and snort or inject them.

"FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous," Keating said in a statement. "Abuse-deterrent technologies should not be the anomaly, they must be the norm."

In recent years, Purdue Pharma, Pfizer Inc., Endo Health Solutions Inc. and other drugmakers have developed tamper-resistant versions of popular opioid drugs.

The timing of the FDA announcement also drew criticism from safety advocates and lawmakers. Only one day earlier the FDA said it would support stronger restrictions on combination drugs containing hydrocodone, including Vicodin and dozens of other generic formulations.

The drugs currently available mix hydrocodone with non-addictive pain relievers like aspirin and acetaminophen. For decades these drugs have been subject to less rigorous prescribing limits than other prescription painkillers like oxycodone.

Late Thursday, the FDA said it would recommend moving hydrocodone combination drugs from the schedule III class to the schedule II class of medications. The switch means that the drugs can only be prescribed by a physician and cannot be refilled. Currently the drugs can be refilled up to five times by the patient can be and prescribed by nurses and other health care workers.

The DEA had first asked the agency to reclassify the drug a decade ago, and lawmakers and safety advocates had increased their pressure on the agency in recent years.

The FDA said in its announcement Friday that the newly-approved Zohydro would be regulated under the schedule II classification.

The agency is also requiring the drug's manufacturer to conduct studies of Zohydro's potential misuse and abuse when used longer than 12 weeks.

The most common side effects reported in company trials included constipation, nausea, drowsiness, fatigue, dizziness, dry mouth, vomiting and itching.

Shares of San Diego-based Zogenix, Inc. jumped in trading Friday, climbing 80 cents, or 36 percent, to close at $3.04. Earlier shares set a 52-week high of $3.45.

 

Comments

Stop It

BAD MOVE!!!!!!

BULLISDEEP's picture
BULLISDEEP

WATCH more people will enter the PRISON SYSTEM .

Stop It

Or die.

I really don't hold much in conspiracy theories, but we really have a pandemic problem with opiates and the crime that goes with such an addictive drug. This is just going to make it worse. Big chunk of cash in this, as well.

abigbear

Lest we not forget that ol’ Ezekiel Emanuel was the one that came up with the, “Complete lives system”. AKA Death panels. Which they told us was completely false, and yet its in Obamacare!

http://freedomeden.blogspot.com/...

neym33

-=-=-Google is paying 80$ per hour! Just work for few hours & spend more time with friends and family. Yesterday I bought a top of the range Lancia after having made $9458 this month. Its the most-financialy rewarding I've had. It sounds unbelievable but you wont forgive yourself if you don’t check it out http://goo.gl/f6e95V

From the Grave

It's simple: check their portfolios for shares of Zogenix, Inc.

Centauri

http://www.usobserver.com/archiv...
"Racketeering Love Triangle:
Monsanto, FDA, Big Pharma

Centauri

http://www.opiate.com/hydrocodone/
"Hydrocodone is a semi-synthetic opiate which means that the drug is synthesized from the opium poppy but does not occur naturally within the plant."

Research "Thebaine"

http://medical-dictionary.thefre...
"a crystalline, poisonous, and anodyne alkaloid from opium, having properties similar to those of strychnine."

The Hero Zone's picture
The Hero Zone

Who needs a liver, anyway? It...like...regrows back or something, right?

Centauri

I figure that you have a high IQ and a lot of common sense. I do follow your comments. Just wanted you to know.

The Hero Zone's picture
The Hero Zone

Thank you. Though...I do have doubts that I undermine myself (whatever my IQ is aside) with sarcasm at times. I appreciate the fact that you went out of your way to say what you did.

Centauri

Admit it, you are very wise at your young age. With age comes wisdom and knowledge. :) Never stop learning and gaining wisdom and knowledge. :)

The Hero Zone's picture
The Hero Zone

Oh I will never stop learning, that's for sure. But I am not the one who can say if I am wise or not. That's up for others to do. There are probably some on here who consider me an idiot. But, with as many different people I have in my life I will not stop learning different topics, points of view, and satirical comebacks.

I think that if I was truly wise I'd be able to find a way to turn that wisdom into a profession beyond what I currently do. But to that end, I'm stumped worse than a legless dwarf.

Ithink

HaHa!

The Big Dog's back

Oh boy, 2 conspiracy theorists now.

ladydye_5

And the people that really need a pain killer? Those that live with CHRONIC PAIN? Who need to have relief? Who gives a flying fig about the pill poppers or the drug addicts who die from overdose? Not my problem, their choice. Why do people with REAL problems and pain need to suffer because of PILL HEADS?

Stop It

Yeah really. They just had a very bad pain or operation and the doc prescribed it to them. They followed the directions and the doc cut em off after a certain amount of time or realized they were using them in the wrong fashion. Then they *needed* more and could not get them legally, so they started stealin' n stuff. Then they found out heroin was cheaper but still could not satisfy the damn craving.

You are an exception , woman. I have witnessed what opiates have done first hand from docs or on the street. I have never witnessed a junkie who just thought it would be fun, but I have seen them die.

I am not apologizing for anyone anyhow. You are opiate insensitive. I can't get a rash from poison ivy or oak or anything related to it even if I ran through a thicket of it. My brothers and many others can just stand downwind from it and break out within hours.

Until you endure the pain that goes with quitting opiates or watching one try, EDIT: it would be kind of you to not condemn those who have.

Centauri

"Until you endure the pain that goes with quitting opiates, STFU."

For shame Stop It, for shame. Please show more empathy to your fellow neighbors.

Empathy: the ability to understand and share the feelings of another.

Stop It

You are right, Centauri. Rephrasing.

cracked

I UNDERSTAND your wanting everyone to experience the addiction.The real casualties of addiction are the ones that love and desire the addict to be released not the addict. Family and friends are the victims of the theft and the lies and watching the one you love go down in flame.So stuff your STFU comment.That is selfish and APATHETIC.

ladydye_5

Do you have a point, other than being an idiot? I am not sure what your comment even means?

Yes....A Pill head- that means instead of finding a doctor that can help then figure out why they are in pain or help them stop the pain/better control it, they find different doctors to give them MORE PILLS.....aka PILL HEAD. They take more and more pills and become addicted. Then people like me who need a few to get thru a weekend when the weather is bad and I need to rake the leaves, clean the yard, have a busy weekend, fall down the stairs or whatever can't. Too many take the easy way out. More pills. Then sell some to get some more. Then when they run out, they find ANOTHER doctor to get some MORE. This is NOT MY PROBLEM. This is THEIR CHOICE. I am sorry if you are offended by this. I have no sympathy for someone choosing to be a pillhead addict. I do NOT choose to be someone with chronic pain. I have medical conditions I canNOT control. I go to doctors. I have therapy. But when the FDA and Insurance company controls how many and what kind of drugs I can get due to PILL HEADS and their addictive tendencies/overdoses it makes me kinda angry.

Stop It

My story as typed a long time ago in a website that deals with addiction, ladydye_5...ENJOY

to All, I fully understand the problems that you think you may know come with prescription painkillers. They grab a hold very tightly. I was in the hospital for both lungs being collapsed. I explained what I went through to ****, close to a year ago. Good thing I wasn't working at the time becuz it took me ten days after 6 months on those DAMN things in my bedroom just getting up to use the bathroom and eat what little I did, to come down and rehab myself. Doc wanted me to stay on them for a year and dropped me after 23 years of bein' my family doc because I didn't!! Gatorade and soup and salad. It was very, very hard to get off those oxycodones. But, they made me consider suicide and I'm not built that way. I know my ex and her husband died from takin' that stuff. It's bad stuff. Not only do you feel no pain, you don't give a (ef) less what other people think. Lights are out! If you do get up and move around, you don't care about anything much, except where that pill bottle is. I never want to go thru that again and I wouldn't wish it on my worst enemy.

Centauri

I suffer from chronic pain. With education, one does not need to be addicted to pain medicine.

In poor third world countries, the people use the whole plant. The knowledge is passed down from generation to generation. Big Pharma doesn't want you to know the truth.

Centauri

Addicted to pain and live a short life?

Use pain relieving drugs with education and live a long better life?

Those poor third world country residents live a long life through passed on education. Opiates and medical cannabis are not a bad thing with proper education and passed on knowledge.

Fromthe419

80 percent of opiates produced in the world are used by 330 million people in the USA and the total population of the world is close to 8 billion, does this tell you anything? We have a problem

SamAdams

Yes, some people have a problem. But you might also look at it like this: In many countries, the drugs are unavailable, unaffordable, or both, and some of THOSE places are the most populous in the world!

Not to worry. Under Obamacare, many people here won't get the treatment they need. Then we can be just like those other places and suffer less addiction and more just plain suffering! Silver linings...

BULLISDEEP's picture
BULLISDEEP

Off by a few million on world pop

http://www.census.gov/popclock/

SamAdams

Yes, there's the potential for abuse and addiction here. Yes, the drug should be prescription only, and those prescriptions shouldn't be renewed over and over again by doctors. But why should people in a great deal of pain suffer even MORE just because somebody else might see their pain meds as a good time?

Anybody who's had a major surgery knows what short term serious pain can be like, and I suspect every one of us who's been there is more than grateful for the pain medications we took! Most people don't turn into addicts. Most people use their prescriptions just as intended. And in the case of someone who's suffering as a result of a terminal condition, well, what does addiction matter?

I'd worry more about the fact that this drug doesn't seem to have had certain tests done on it than I'd worry about whether or not somebody somewhere gets addicted to it! In truth, in many cases, the natural compounds are more effective and less dangerous than the chemically modified drugs. But since that doesn't make the pharmaceutical companies as much money, well...

Unassumer

I don't think most people get addicted to pain meds from having chronic pain, although I'm sure there are some. Those that take it recreationally are the problem. They also turn to selling it. Those people are the problem and it does make it more difficult for the person that really needs them to obtain them. Also, making a stronger version of a drug that many are already addicted to is just setting them up for a worse fall. I don't like pill heads either and I certainly don't think the FDA should contribute to making more but some people legitimately need pain meds.

Centauri

http://stopthedrugwar.org/taxono...
"Under-treatment of Pain"

http://stopthedrugwar.org/chroni...
"Dr. Shaygan's Saga: Prosecutorial Misconduct in the War on Pain Docs"

"Part 4 in a series, "Prosecutorial Misconduct and Police Corruption in Drug Cases Across America."

"But justice hasn't prevailed just yet. The federal prosecutors who engaged in the misconduct have not been punished for their actions, either criminally, professionally, or financially."

Here is some good reading about pain medications. There is no reason why somebody should have to suffer from chronic pain. I have said this before and I will say it again. I don't understand why some people want to use pain drugs

WeThePeople1965

I'm sure that with its' passing by the FDA comes a hard time for people- addicts or not- to get their hands on it. Physicians (with the exception of pill mills........) probably wont prescribe this- even in an inpatient setting- unless there's an extreme case of pain. With that said, I have no experience with this new drug, I just know it was approved, so I really can't tell exactly how strong and effective it will be, other than it'll be at least a little bit more effective than Vicodin. It will be another highly abused drug, that's a given. Abuse is a whole different discussion, however. The real problem is that there's patients who actually need the drug, who are in substantial pain and can only function minimally on a high-powered pain med, and there's patients that screw with the system that don't need high-powered drugs, and might not even need pain meds, but actually need a job and money or psychological help. It's a very rough subject, because nobody knows what to do, and addicts are hard to bring to recovery. There's no way that drug abuse will ever stop entirely.

KURTje

Centauri brings valid points. Smithsonian Magazine did an article on Eli Lilly/ Merck /Big Pharma. One of those groups went into the Amazon Jungle years ago to learn from the "poor" natives on how they anesthetized other people in their tribes for "body repair." Those folks utilized plants around them. Similar to unrefined extra virgin coconut oil. (Lactic Acid..hmm) Look at our past and the Harrison Drug Laws around the turn of the century.