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Is The Super Potent New Opiate Painkiller Zohydro Just Too Dangerous?

Rating:
4/5,
  1. SpatialReason
    Screen-Shot-2014-02-28-at-1_25_34-AM_1_.png
    A new opiate painkiller with 5 to 10 times the power of Vicodin, set to hit the market in March, could trigger a disastrous spike in overdoses and deaths, says a powerful coalition of doctors, lawmakers, and addiction specialists.

    In a strongly worded letter that could be titled “Just Say No to Zohydro” more than 40 experts urged the Food and Drug Administration (FDA) to reconsider its approval of Zohydro ER, a potent extended release formulation of straight-up hydrocodone, citing its potential to add to the growing epidemic of painkiller addiction.


    “In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the experts wrote, addressing FDA Commissioner Margaret A. Hamburg, MD.

    One member of the letter-writing coalition, Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, was more blunt: “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released.”

    This isn’t the first group of experts to beg the FDA to reconsider. A coalition of Congressional representatives and state Attorney Generals has also urged the FDA to listen to its own advisory panel, which voted 11 to 2 against approving Zohydro.

    What’s all the fuss about? Plenty. Zohydro is so strong that someone new to opioids could die of an overdose from just two pills, the experts say. And a child could die from ingesting just one capsule. According to the FDA’s review, the relief – or the high – of Zohydro can last up to 12 hours per dose.

    The CDC’s data on opioid painkiller deaths speaks for itself, showing that deaths quadrupled in a ten year period. Between 1999 to 2010, the number of U.S. drug poisoning deaths involving an opioid analgesic went from 4,030 to almost 17,000, now topping those from heroin and cocaine combined. CDC data show that prescriptions for painkillers have nearly tripled over the past two decades, and 5 million Americans are dependent on the painkillers.

    There’s no disagreement that we’re in the middle of an epidemic of painkiller abuse. Since 1999, the U.S. has seen deaths from opiate painkillers jump by 415 percent in women and 265 percent in men. And this isn’t just black-market drugs – the biggest victims are middle-aged men and women legitimately prescribed the drugs for chronic pain, the experts say. Nearly 60 percent of all drug overdoses are from FDA-approved prescription medications, not illegal drugs. According to Forbes’ own Robert Pearl, MD, 3 in 4 drug overdose deaths are due to an opioid painkiller such as oxycodone, hydrocodone or methadone.

    The question, experts say, is do we need a new opiate painkiller at all, given that we seem unable to prevent the ones we already have from ending up in the wrong hands? A drug this strong has enormous potential for abuse, and the U.S. does not have a good track record in preventing that from happening. The death of Philip Seymore Hoffman put a spotlight on the potential of oxycodone, Vicodin, and other painkillers to set people up for heroin addiction, which has also been on a rapid rise in the U.S. over the past few years.

    The U.S., with just 5 percent of the world’s population, now accounts for 84 percent of global oxycodone (Oxycontin) consumption and more than 99 percent of hydrocodone (Vicodin, Lortab) consumption. That’s a lot of painkillers.

    Zohydro ER was approved by the FDA on October 25, 2013. Pharmaceutical experts have expressed surprise that Zohydro was approved without an “abuse-deterrent” formulation, which means a formulation including additives like naloxone or niacin that cause unwanted side effects when the drug is snorted or injected but are tolerable when taken orally as prescribed.

    The primary thing that sets Zohydro apart – other than its strength – is that it doesn’t contain acetaminophen, as Vicodin does, and it’s on this basis that its maker, Zogenix, has argued that it’s safer than the alternatives. That’s simply not true, argue its opponents, who point out that there are plenty of other opiate painkillers already on the market that don’t contain acetaminophen. Zohydro is expected to be available as early as March.

    In addition to Kolodny, the coalition, which calls itself Fed Up, unites doctors, pharmaceutical industry experts, advocacy groups, and addiction specialists, including G. Caleb Alexander, MD, Co-director of the Johns Hopkins Center for Drug Safety and Effectiveness; Stuart Gitlow, MD, President of the American Society of Addiction Medicine; Daniel Busch, MD, of the Feinberg School of Medicine at Northwestern University.

    In response to previously expressed concerns, Zogenix has established a safe-use board of experts outside the company to aid in overseeing “appropriate use” of the drug.

    Melanie Haiken
    Contributor
    Forbes.com
    2/28/2014 @ 5:30AM

    http://www.forbes.com/sites/melanie...ent-new-opiate-painkiller-just-too-dangerous/

Comments

  1. xsiv1
    For some people, the pain they experience, especially during a terminal illness, should get whatever drug and drug potency that will keep them comfortable. The FDA recently issued an import alert against Kratom coming from Indonesia, Malaysia and even Canada despite the fact that many addicts have gone off harder drugs and onto a more benign plant. They can essentially seize any package without due aforethought. When Big Pharma wants something...er
  2. Xplicit
    IMO it won't make much of a difference if they approve it or not. People will die from ODs with Vicodin and Percocet just as much as with this new drug. Its just people have to be smart enough to know how to take a drug responsibly and keep it away from kids RESPONSIBLY. Not putting it in an unlocked cabinet in the kitchen, my parents where not responsible prescription drug user either, all I had to do was jump onto the counter at the age of 12 and I'd get high on my moms Oxycontin or take a nap with her Ambien. If that shit was around when i was a kid and my mom took it I'd be dead by now but if she was responsible with it and kept it somewhere very safe and secret none of this shit would happen.

    Its a matter of people being responsible, these people saying don't approve are treating the drug using public like children, "Oh no these people are going to leave their pills out in the open for their kids to take and die of an OD or everyone who gets prescribe this is going to abuse this and OD. Personally I'am a drug abuser, I abuse prescription pills but I'm still responsible with my usage of pills to get high. But with this new drug, I'd know better then to mess with something as strong as this and any responsible drug user should know better then to mess with this. I'd have to say this is strictly a use as prescribed drug no questions asked unlike Percocet or Vic where you can maybe take a few extra then prescribed but being honest this to me looks like a drug you don't want to fuck around with.
  3. baZING
    I'm just so sick and tired of the media throwing around the concept of potency without any regard for what it actually means. Obviously this drug is no more potent than Vicodin or other existing hydrocodone products; it's the same damn thing. Sure it comes in larger doses per unit, but this isn't the same as being more potent. These pills are not full of sufentanil, etorphine, or some other, actually "hyper-potent" opioid. This is still the same drug that is less potent than many commonly used narcotics.

    I don't think their argument is serving them well, that there are already so many painkillers on the market so why do we need another. The fact is, there AREN'T a lot of options for people who find that hydrocodone simply works better than others. Some of this is psychological; there's not a lot of difference between plain-old full-agonist opioids when dose is adjusted but who the fuck cares. If a patient can find more relief from one drug over another, I say more power to them even if the benefit is all in their head. There's such a huge psychological component to chronic pain that I don't think it can be discounted, anyway.

    As of right now, those people who prefer hydrocodone can only take 10-20mg at a time, and only immediate release. That's it. While it might seem like an unnecessary addition to the existing arsenal of pain medicine for those who don't suffer, I have no doubt it my mind that it will completely change some people's lives.

    In fact, I think it would be great if MORE people on opioids could find relief from something like hydrocodone, which in the grand scheme of opioids, is decidedly on the low end of the potency scale. I'm not saying that people don't become physically dependent and/or addicted to hydrocodone just the same way they might to any other opioid; of course they do. But Zohydro is opening up a previously unavailable option that is frankly a little bit better than many other extended release alternatives. Oxycodone, oxymorphone, hydromorphone, and fentanyl are all more potent than hydrocodone. Morphine is of equal strength when both are taken by mouth, as ER medicines generally are. Before now, those were basically the other extended release options. God forbid we give patients-- some of whom are dying-- another choice in receiving care, I guess.

    If I'm being honest, I think all these people who clearly do not suffer from pain and have little concern for the actual patients versus drug addicts need to STFU and if the media wants to continue reporting on this drug they should continue getting their damned facts straight.
  4. Docta
    There seems to be a misunderstanding as to what Zogenix Corp are doing here. They are not a pharmaceutical company they are involved with next gen drug delivery systems. This new product is no stronger than vicoden because the delivery system prevents abuse. In fact it is safer because of the low abuse potential.

    The members of the DF chem section are very clever so you would think that if anyone could defeat Zogenix's new time release it would be us. Well this is cutting edge shit and if your looking to get high it won't be of any capsules with Zo in the start of there names.
  5. baZING
    Docta, I think you're a little confused. Unless you have information stating the contrary, Zohydro will most likely NOT be tamper-resistant when it first hits the market. I saw an article suggesting that Zogenix is in talks with a third party to create a tamper resistant formula and if they can do it before release they will, but their new drug delivery system is simply that of an ER hydrocodone... Not one that is specifically hard to abuse. That is a large part of the backlash, that as of very recently at least, Zohydro was approved knowing full well that it does not employ any sort of tamper-deterrent formula.

    This might have changed but I'm certain this was true initially, as this was cited as one of the reasons for the FDA advisory panel recommending against Zohydro's approval.

    I used Zogenix's other med on the market, Sumavel, which does use a pretty unique delivery system but they had all kinds of problems with it. I wonder if they ultimately simplified the Zohydro delivery system as a result.

    Teva's new/upcoming ER hydrocodone has been tamper-resistant from the start.. Is this what you're thinking of maybe?

    I'll look for some links later if I remember but I'm on my phone right now.
  6. babalooj
    Docta wait,
    So these new pills are abuse proof?
    Like i won't be able to crush em, and eat em like they were instant release, plug, or snort these?
  7. baZING
    They will be pretty easy to abuse, unless steps are taken by Zogenix to change the formula before it hits the market. Here's something I found on a website whose name I can't say because it contains a message board. I can't be sure it's 100% accurate, but the website in question is one of the largest ones dedicated to the field of medicine as a whole. At any rate, this corroborates everything else I've seen written about this drug.

  8. Docta
    This drug is designed for a narrow market of pain control and poor quality-of-life outcomes, it is not patient-controlled analgesia.
    This drug will be administered by the care provider, the patient should never be in a position to control dose.

    [imgr=white]http://www.drugs-forum.com/forum/attachment.php?attachmentid=37614&stc=1&d=1394091516[/imgr]All opioids are subject to FDA Abuse-Deterrent so to have people kacking on about Zohydro ER abuse potential like its not subject to federally mandated regulation seems like a bit of a propaganda show to me. The most basic investigation of present invention for Zohydro ER at the consortium manufacturing the drug: Altus Formulation Inc, Alkermes Pharma Ireland Limited and Zogenix, Inc. point to some bad ass hard to abuse shit under the parent term: Multiparticulate Modified Release Composition. Elan Drug Technologies have licensed out the new gen SODAS (Spheroidal Oral Drug Absorption System) delivery system that nobody has even seen yet. All we know for sure is its better then the earlier generations they licensed out for Avinza, Ritalin LA, Focalin XR, and Luvox CR.

    Unless Alkermes are throwing up some kind of smoke screen that is obscuring my understanding as far as I can tell Upsher-Smith Laboratories, Inc have released the invention described in Patent US 8362029 B2 for use in conjunction with SODAS. This hydrophilic matrix system is very hard to extract from and can not be injected or snorted. I'm confident I'm reading the correct documents that were presented with the revised application to the FDA. I suppose we'll just have to check it out when the first lot hit the market place.

    RE: propaganda wars
    Dr Jason Jerry, Department of Psychiatry and Psychology at Cleveland Clinic.

    Jason Jerry, MD is retained by Reckitt Benckiser Pharmaceuticals Inc the manufacturer of Suboxone, principle market competitor to Alkermes Pharma Ireland Limited who manufacture Vivitrol. (naltrexone) Alkermes starting production of Zohydro ER could lead to Vivitrol cutting into Suboxone's slice of the pie. Big pharma simply cane not be trusted.

    Edit: almost forgot the anti abuse future system that is being touted for Zohydro ER is looking like PharmacoFore, Inc's PF329 system.

    If they go PF329 its gameover
  9. baZING
    This part is just plain wrong, Docta. Where on earth did you get that from? This is a pill, that will be prescribed by a doctor for a patient to go pick up at the pharmacy and take at home. It is, indeed, patient-controlled analgesia. Zohydro is going to fulfill the same purposes and needs as other, existing ER medicine on the market and it will be prescribed and consumed as such. It will definitely NOT be administered by the care provider past being given a prescription to take to be filled, once again the same as all other at-home medication.

    As for the rest, we will have to see, but I don't think the patent you linked to has anything to do with Zohydro. What made you think it does?? Obviously I'm missing it. Granted I only skimmed but I'm a fast reader, and it appears that the formulation mentioned in the patent is one that will contain BOTH an opioid and an NSAID; this isn't Zohydro. There is of course a [slim] chance they could use the same system for Zohydro, but as far as I can tell that patent info is not talking about this drug and I have heard nothing to suggest Zohydro is going to be mixed with an NSAID. That's the whole fucking point of it... that it's plain old hydrocodone in an ER dose. I can't help but believe if Zohydro were actually being released with a tamper-deterrent formula, or in combination with an NSAID the way Vicoprofen already is, there'd be a little less hoopla.

    Keep in mind that there is also a difference between a drug being retroactively produced with a tamper-resistent formula after hitting the market and being released this way from the get-go; it sounds like the former is what's happening.

    I also think your assertion that Zogenix is not a pharmaceutical company is incredibly misleading. They are as much as a pharmaceutical company as something like Pfizer; they just happen to focus on innovative drug-delivery systems. Zohydro is only their second product.

    On their very first page it says "We are a pharmaceutical company providing innovative therapeutics focused on CNS disorders and pain."

    http://www.zogenix.com/index.php
  10. I_MISS_160s
    Not to mention, what if this new pill lowers the amount of Heroin abuse? That would suck huh?

    Shit

    I fucking hate my government
    160


    DONATE DAMN IT

  11. baZING
    edit: I stand corrected, Zohydro does indeed use the SODAS system, or at least something similar. However, I was under the impression that capsules using SODAS are extremely difficult to get around for those who intend to abuse them; from all I've read now that the drug has been released in limited capacity, it is indeed pretty easy to abuse. Based on what little information I could find back from much earlier in Zohydro's existence, this was not the original plan. The earliest versions of Zohydro seemed to have had a design much more similar to, say, MS Contin or even the original OxyContin. I do not know that any of these were actually produced, however.

    It also may be that the SODAS system is simply not that hard to "break through." One brand of ER morphine that absolutely does use SODAS still warns against patients crushing the spheres contained within the capsules, so that doesn't make it seem like they have a lot of faith in its resistance to abuse. /edit

    http://www.alkermes.com/Research-and-Development/Technology-Platforms

    One of those technologies is already being used in an existing drug called Ampyra (dalfampridine), which is for MS. It's not a recreational substance so there's not a lot of incentive to crush or abuse them, but from what I can tell it is absolutely possible with minimal effort (i.e. by chewing). To be clear, the "oral controlled release technologies" described on the Alkermes page include a couple of different formulas; however, nowhere does it suggest any of them are abuse-deterrent and I have seen a number of things to suggest the one currently being used for Zohydro is the same that is used for Ampyra.

    This does not discount the possibility that Zohydro will eventually use the SODAS system, or something else equally tamper-resistant.

    That said, it is doubtful that such change will be made so close to launch, which is due to take place literally any day if the product hasn't already begun distribution. All release information I saw pointed to early March.

    The lack of abuse-deterrent technology was the primary reason for the FDA advisory board recommending against its approval... but obviously this was ignored by the voting committee.
  12. Docta
    I'll have to concede that one. When seeing, "first hydrocodone product to be subject to the FDA’s class-wide Risk Evaluation and Mitigation Strategy (REMS)" I had assumed FDA's REMS guidelines to be the same as the AAFP’s Collaborative for REMS Education (CO*RE) as seen in CMEbulletin. Physicians prescribing this medication will in a perfect world be following medication scale and application from CO*RE, but this is not a perfect world. There is a possibility that a patient could walk out of a pharmacy with this medication, well walk may be pushing it lets say crawl. The level of disability here is a pain level beyond that what can be elevated with MS Contin 200mg administered every 8 hours.

    Here it gets tricky, The COMMERCIAL MANUFACTURING AND SUPPLY AGREEMENT (CM&SA) became effective as of November 2, 2012 making any and all information submitted before or in the confidential treatment document under copy protection. Certain information on the agreement has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. THE SECURITIES AND EXCHANGE COMMISSION has granted confidentiality. Keeping this in mind I will attempt an explanation.

    Chemistry minded individuals have awaited hydrocodone products without acetaminophen with great anticipation from there beginnings in 2006-2007 until present day. Zogenix have beaten Egalet, a Denmark-based pharmaceutical company to market, but expect Eaglet to catch up fast in 2016-17. Along the way about 6 or 7 years of data is amassed giving insight into the machinations going on behind the R&D and the economics of getting all the ducks in a row when it come to patent royalty's.

    Imagine if J.P. Morgan healthcare held the patent's omitted from the CM&SA they would effectively be paying themselves to make money. No way!

    [​IMG]

    In the FDA notice of disclosure Alkermes lists Patent Nos.: US 6,228,398 and US 6,902,742 as primary's for Zohydro, but they look like the same patent except for some new patent citations applicable to opioids and impossibly long list of reassignments starting with Elan Pharma in 2008 and ending with Alkermes Pharma paying an eight year patent extension in 2012, about 3 weeks after Zogenix handed over the check. CM&SA effective date November 2, 2012. Stop! "Elan Pharma in 2008" that's the SODAS people what the hell............. Who bankrolling this deal? Morgan Stanley Senior Funding, Inc. main asset hedge for JP Morgan Chase Bank?.. How to get it from Elan Pharma in the Ireland to Alkermes in Ireland then back into patent royalty pool for J.P. Morgan?
    [​IMG]

    [​IMG]

    "Elan Pharma in 2008"...Hmmm 2008 hard time to be doing business in Ireland, financial and corporate markets crashing. Who was it exactly that secured a rollover on there $200,000,000, note, Cahill Gordon & Reindel I hear you say?... Surly not, underwriter's counsel to JPMorgan and Morgan Stanley.

    And all a result of a License Agreement dated November 27, 2007 between Elan Pharma International Limited (“EPIL”) and Zogenix.

    All statements made here are a matter of public record and in on way infringe upon rulings of relevant Governmental Authority's.

    You say potato and i say potarto......... Until a bioTech company has a hand in making something on the U.S. Pharmacopoeia I don't consider them a Pharma.
  13. ZenobiaSky
    FDA chief defends new pain drug despite worries about abuse

    FDA chief defends new pain drug despite worries about abuse

    [IMGL=WHITE]http://www.drugs-forum.com/forum/attachment.php?attachmentid=37805&stc=1&d=1394955797[/IMGL] (Reuters) - The head of the Food and Drug Administration on Thursday defended the agency's approval of Zohydro, a powerful prescription opioid made by Zogenix Inc, saying it offers a "unique" option to treat pain despite concerns about potential abuse.

    The FDA's approval of the drug has drawn a flood of criticism, including protests from the attorneys general of 28 states as well as dozens of groups representing doctors and addiction treatment specialists who are concerned that Zohydro will set off a wave of addiction similar to problems with the original form of OxyContin, another opioid.

    These critics have petitioned the FDA to consider pulling the drug's marketing approval.

    FDA Commissioner Margaret Hamburg, testifying at a Senate hearing, acknowledged that Zohydro is "a powerful drug" but said "...that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy."

    Her comments to the Senate Health, Education, Labor and Pensions Committee come barely a week after Zogenix said it was making the painkiller available at "select pharmacies" following the drug's FDA approval in October.

    In approving the drug, the FDA overruled its panel of outside advisers, who had recommended against approval, citing safety concerns about the potential for abuse.

    Shares of Zogenix rose more than 5 percent after Hamburg's comments, before slightly paring gains to close up 4.6 percent at $3.67 on the Nasdaq.

    In her comments at Thursday's hearing, Hamburg said the FDA,

    in approving Zohydro, recognized "...its addiction potential and understanding, of course, the broader context of the serious problem of opioid medication abuse and misuse in this country."

    Zogenix last week, in its statement on quarterly results, said it is "taking a measured approach to commercialization." Representatives for Zogenix told Reuters on Thursday that the company had no further comment.

    A recent study of government data found that, on average, more than 12 million people age 12 and older were estimated to have used prescription opioids at least once a year to get high.

    Senators at the committee's hearing echoed worries about abuse, noting the Zohydro is not made in a way to thwart crushing or chewing of such drugs to get a high.

    "The concern that I think a number of us have ... (are) about the implications of allowing this new product on the market without these abuse deterrent properties," said Senator Robert Casey, a Democrat from Pennsylvania on the panel.

    Senator Joe Manchin of West Virginia, whose state has been particularly hard-hit by prescription drug abuse, earlier this week called on U.S. Health and Human Secretary Kathleen Sebelius to overturn the FDA's approval.

    "Americans are abusing, and (in) many cases dying, at an alarming rate from highly addictive pain medicine, and it is shameful that the FDA would ignore its own experts to approve this drug," Manchin said in a statement after the hearing. He later introduced legislation that would ban Zohydro.

    Hamburg said unlike other approved hydrocodone drugs, Zohydro does not contain acetaminophen, which can be toxic to the liver. She also said other factors, including doctors' prescribing practices, play a role in drug abuse.

    Abuse of OxyContin became so widespread that manufacturer Purdue Pharma changed its formula in 2010 so that the drug could not be injected or snorted as easily. On Wednesday, Purdue said it was moving ahead with an abuse-resistant rival to Zohydro.

    Zogenix last week also said it is making progress on another version of Zohydro to deter abuse.

    "I would love if we had abuse-deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. We are moving in that direction," Hamburg told lawmakers. "Right now, unfortunately, the technology is poor."
    She added that the FDA is working on guidelines to help manufacturers come up with more effective abuse deterrents but gave no timeline for when the guidelines would be finalized.

    Developing more non-opioid pain drugs could also help prevent misuse, she said.

    "Acute and chronic pain needs to be treated. Opiates are very effective for acute pain, less effective for chronic pain, but we don't have a lot of good alternatives at the present time," she told the Senate panel.

    Hamburg also said more attention needs to be paid to the overdose-reversal medication called naloxone, which could save more lives if it was easier to use and more widely available.

    The FDA is urging drugmakers to develop other forms of the injectable drug such as a nasal spray or an automatically injectable version, she added and has been encouraged by their response, she said.

    BY SUSAN HEAVEY
    WASHINGTON
    Thu Mar 13, 2014 4:28pm EDT
    Reuters
    http://www.reuters.com/article/2014/03/13/us-zogenix-zohydro-fda-idUSBREA2C22S20140313

    The Newhawks Crew
  14. bearman94
    Well,
    In harm reduction terms it takes out all the advil and Tylenol addicts bomb their livers with
    something to think about I guess?
  15. BitterSweet
    I didn't read some of the replies in this thread so I may be repeating things that have already been said. I agree with baZING (at least the first reply of his that I read). The media ignores the reason for having another prescription painkiller available for prescription. Pain meds seem to be only looked at in terms of what kind of impact they will make on the epidemic of abuse of pain killers, completely ignoring the impact such a move will have on pain management. That's pretty much what has already happened on the subject of pain meds. Pain meds are now only being looked at in relation to how they can be and are abused. That's like how OxyContin was taken off the market here in Canada and replaced with OxyNEO, which is tamper resistant (but since addicts tend to be very creative specimens, there are already a few ways to deal with the tamper resistant mechanisms, although these methods are time consuming, and the end result is not really that great).

    It's very true that some opiates work better for some people compared to others. Hydrocodone is one of the weaker opiates, and mostly one can usually only obtain them as percocets, which results in having to take acetaminophen (basically here in Canada my understanding is that hydrocodone is only available as percs, which contain large amounts of acetaminophen, meaning only low doses of hydrocodone can be taken without risking harm to the liver; and for XR hydrocodone, there is only OxyNeo since OxyContin was taken off the market - and many who were on OxyContin for pain treatment find OxyNeo to be an inadequate replacement).

    So people can look at zohydro as adding fuel to the fire, but that is because their opinion is emerging from the wrong thought process. The article also says that the drug is so strong that opiate naive individuals could die from 1 to 2 doses; but opiate naive individuals could die from any opiate that is strong. Opiate naive individuals could overdose and die from taking OxyContin, or hydromorphone, or anything. Opiate naive individuals have this universal risk among all opiates. And I'm assuming doctors would have enough sense not to start an opiate naive patient on this drug. Usually other medications to treat pain are tried first before moving to opiates, and even when a person starts testing out opiates, low doses of opiates are prescribed - say someone might at the beginning be prescribed 2 mg of hydromorphone. So the biggest risk of opiate naive individuals dying from zohydro is that if they are bought illegally and taken recklessly.

    Individuals can do just the same with other opiates, buying them illegally and using them despite using a dose that is too high. The purpose of releasing this medication is to address pain management, and not on behalf of illegal drug users. People who choose to use opiates illegally in an unsafe manner, to a point where they overdose or even die, should not be considered before those needing pain management. That's basically a slap in the face to people who could really benefit from zohydro, saying, "well, there are people who might use this drug to get high and use it in large enough amounts that will cause problems. So tough luck, because they are being considered first". And then the patient responds, "but hydrocodone really helps with my pain compared to the alternatives, and this new formula could finally offer a better way to access the amount of hydrocodone I need without the risks of drugs like percocet that include acetaminophen".

    Look at this quote from the article:
    It will kill people as soon as it's released? How about it will help and save people as soon as it's released? People with such an opinion act like zohydro is the only drug that is dangerous, as if it is the only drug with high potency. For the people who choose to abuse this drug, that is their own choice, and their misuse should not impact people who could really benefit from it. Plus, users who might use this drug recreationally aren't all opiate naive, and will be able to use it without overdosing and dying, so yes it's illegal activity but it can be used just the same as every other opiate used illegally.
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