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posted by janrinok on Saturday March 01 2014, @12:01AM   Printer-friendly [Skip to comment(s)]
from the one-should-be-more-than-enough dept.

GungnirSniper writes:

"Pharmaceutical company Zogenix has received US FDA approval to launch a new hydrocodone-based analgesic in March. The drug is intended only for chronic pain, not as an short term or as-needed analgesic. CNN is reporting a coalition of groups are lobbying for the FDA to revoke their approval before the medicine is even available.

The concerns echoed by all groups are broadly about the drug's potency and abuse potential. They say they fear that Zohydro especially at higher doses will amplify already-rising overdose numbers.

'You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now,' said Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. 'I'm five times more concerned, solely based on potency.'

A number of other news outlets are hyping the potency of Zohydro, going so far as calling the drug ten times more powerful than a 5mg Vicodan. A fairer comparison may be to OxyCodone, since they have similar opioid levels. Zohydro ER will be available in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg strengths.

Chemistry Soylents can find the structural formula for hydrocodone bitartrate on RxList.

Should the FDA allow such a potent medication on the market? Or would moving opioid analgesics to Schedule II mitigate the potential for abuse?"

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  • (Score: 5, Informative) by mrbluze on Saturday March 01 2014, @03:38AM

    by mrbluze (49) on Saturday March 01 2014, @03:38AM (#8954) Journal

    Reading the full product information, I can't see why we need yet another opioid. It's a phenanthrine alkaloid, so it is probably dirt cheap to make, which means profits for pharmaceutical companies. It is long acting, but we already have very cheap long acting drugs like Methadone, Oxycodone SR, Targin (Oxycodone + Naloxone) and Buprenorphine which gives us a very wide spectrum of long acting opioids.

    This drug should never have been given FDA approval because it doesn't add anything new except another drug that will take a long time before it's out of patent.

    The alarmism that it will cause overdoses over and above existing drugs and so on is not really something unique. All the opioid drugs cause that already, and every time a new opioid drug comes out there is a new wave of overdoses until people lose interest in it.

    --
    Do it yourself, 'cause no one else will do it yourself.
    • (Score: 5, Informative) by SacredSalt on Saturday March 01 2014, @04:54AM

      by SacredSalt (2772) on Saturday March 01 2014, @04:54AM (#8967)

      This is a narrow market product. Its intended for those whom are successful in managing their pain with 6-10 Norco's per day. Hydrocodone is roughly equipotent with morphine, this doesn't make it strong, actually more toward the weaker side of the opioid family. The main advantages of this drug are that it doesn't contain tylenol, and that it makes dosing more convenient than the 4 hour dosing that comes with regular formulations of hydrocodone.

      The tylenol is an issue over time. Vicodin is the most prescribed pain killer in America. Its fine to take 3-4g of tylenol for a week or so, but it quickly becomes a problem when used for years on end. I do wish they would compound APAP with NAC to reduce the damage to the liver, but my personal feeling is that the tylenol wasn't added so much to boost the effect of the drug but to put a ceiling on its practical use. This reformulation with a time release simply raises the limit a slight bit. No real problem.

      As to abuse, they already incorporate a gelling feature. This makes the resulting drug nearly impossible to inject. It probably doesn't do anything to discourage people crushing or inhaling it.

      • (Score: 2) by SMI on Saturday March 01 2014, @05:09AM

        by SMI (333) on Saturday March 01 2014, @05:09AM (#8970)

        Adderall is specifically designed so that it can't be absorbed through the sinus cavity, hence inhaling it would be a waste of time. This could be designed like that, too, but I don't claim to know for sure.

      • (Score: 1) by pixeldyne on Saturday March 01 2014, @05:09AM

        by pixeldyne (2637) on Saturday March 01 2014, @05:09AM (#8971)

        I'm confused. Tylenol is a brand name, did you mean to say that 3-4g of acetaminophen/paracetamol is OK per day?

      • (Score: 2, Interesting) by pixeldyne on Saturday March 01 2014, @05:23AM

        by pixeldyne (2637) on Saturday March 01 2014, @05:23AM (#8976)

        Nothing is impossible to inject for addicts. Safety concerns never come into the equation when the primary driver is to stave off withdrawal and get "just one more hit". That includes injecting vomit (if it contains even traces of opiates.

        • (Score: 2, Funny) by davester666 on Saturday March 01 2014, @05:55AM

          by davester666 (155) on Saturday March 01 2014, @05:55AM (#8981)

          Man, I hate going chunky-style. It always gives me the weirdest dreams.

      • (Score: 2) by mrbluze on Saturday March 01 2014, @06:55AM

        by mrbluze (49) on Saturday March 01 2014, @06:55AM (#8999) Journal

        Nearly none of the opioid drugs that fall in this class come with acetomenophen included. This is not a codeine replacement. As for twice daily dosing, this is already the case with Targin (oxycodone + naloxone) which, if taken by any route other than oral, doesn't work due to the naloxone. I still don't see the use of this new medication.

        --
        Do it yourself, 'cause no one else will do it yourself.
    • (Score: 2, Interesting) by umafuckitt on Saturday March 01 2014, @01:41PM

      by umafuckitt (20) on Saturday March 01 2014, @01:41PM (#9102)

      except another drug that will take a long time before it's out of patent.

      And that, of course, is probably the point. It's all about the patents. They will even release drugs less effective than previous ones, or with worse side effects, and market it aggressively as being better. This has been documented; the citations are on Ben Goldacre's blog and in his book.

    • (Score: 1) by xtronics on Saturday March 01 2014, @06:48PM

      by xtronics (1884) on Saturday March 01 2014, @06:48PM (#9189) Homepage

      Why not another one?

      More competition is better - may have a different set of side effects - lowers costs. Of course I have this old fashioned idea that my body belongs to me - is my business not the government and what I put into it is my business.

      I like freedom - and I like having the freedom to do stupid things if I want - and if I'm dying with painful cancer, I want free access to any opiate of my choice - not your choice - not the government's choice.

      If you want someone to limit what you can do - why not join some S&M club where you can get a master?

      • (Score: 2) by mrbluze on Saturday March 01 2014, @08:44PM

        by mrbluze (49) on Saturday March 01 2014, @08:44PM (#9223) Journal

        Go ahead have it, but the way the system is run this is just a license to print money for a drug that, if you read the product information, has the same side effect profile as the others. It's a morphine derivative, so allergy to one will give allergy to the other.

        --
        Do it yourself, 'cause no one else will do it yourself.
        • (Score: 1) by xtronics on Wednesday March 05 2014, @06:56PM

          by xtronics (1884) on Wednesday March 05 2014, @06:56PM (#11462) Homepage

          Not really - they have differing half lives and even slight differences can prevent and or cause side effects.

        • (Score: 1) by xtronics on Wednesday March 05 2014, @07:36PM

          by xtronics (1884) on Wednesday March 05 2014, @07:36PM (#11479) Homepage

          Also - having more choices and suppliers would lower the cost not raise it (remember when we had one choice for long distance? )

  • (Score: 5, Informative) by pixeldyne on Saturday March 01 2014, @03:46AM

    by pixeldyne (2637) on Saturday March 01 2014, @03:46AM (#8956)

    Being 5 times more potent than what they're dealing with now (what is it?) makes it about the same strength as heroin and an order of magnitude weaker than fentanyl.

    • (Score: 4, Informative) by SacredSalt on Saturday March 01 2014, @05:24AM

      by SacredSalt (2772) on Saturday March 01 2014, @05:24AM (#8977)

      It would be more accurate to say that the new formulation has versions of it which contain up to 5x as much hydrocodone as was available in standard formulations; specifically 50mg of hydrocodone in the maximum dose tablet of Zohydro versus 10mg in Norco a hycodone/APAP combination.

  • (Score: 1) by TGV on Saturday March 01 2014, @06:43AM

    by TGV (2838) on Saturday March 01 2014, @06:43AM (#8992)

    I've been on Oxycodone for a short period. It was a very weird sensation. It basically numbed me almost completely. Quite logical, but not an experience I'd like to repeat.

    That said, that med is already on the market, and the new med is also prescription-only. So there almost can't be a problem with the medicine per se. The article also clearly mentions that over-prescribing is the problem. So why not address that, and make the manufacturers open/support clinics that help people that have become dependent on their products?

  • (Score: 4, Insightful) by sjames on Saturday March 01 2014, @06:49AM

    by sjames (2882) on Saturday March 01 2014, @06:49AM (#8994) Journal

    I really think the people wanting doctors to be stingy with the opoids have never felt real pain. They think a paper cut is a 9.5 out of 10. Let them experience blackout level pain just once where they have no idea when it will end (or at least dull down a bit) and suddenly they will understand.

    And those ODs on prescription opiods? Many of those were no accident. I am thankful I've never been there but I can well imagine that chronic pain can get bad enough to keep upping the dose until the pain or breathing stops, whichever comes first.

    • (Score: 4, Informative) by Anonymous Coward on Saturday March 01 2014, @07:35AM

      by Anonymous Coward on Saturday March 01 2014, @07:35AM (#9011)

      "I can well imagine that chronic pain can get bad enough to keep upping the dose until the pain or breathing stops, whichever comes first."

      Happens more often than most pain treating physicians would care to admit to themselves. Its not usually just one drug, but a multiple of drugs. "I"m hurting and I just want to get some sleep" is the scenario I see most often. So they double or triple down on their pain medicine, take a couple doses of carisoprodol (Soma in the US), maybe throw a few benzodiazepines in the mix. Each one of these starts having an additive effect to analgesia, but also to respiratory depression. Then if they still don't get to sleep, they pour themselves a glass or wine or have a beer. 20 minutes later a situation that was merely taking a little more pain meds than prescribed has turned into one where they stop breathing unless you consciously shake them to wake them out of their stupor. They may have handled the same doses prior dozens of times, but maybe their pain suddenly dropped or they had one more drink.

      Thankfully most overdoses are very slow events, but for those with chronic pain who live alone this can easily escalate into a fatal event. The unfortunate thing is the non-compliant chronic pain patient who shows up at an ER with this scenario looks exactly like the poly drug abuser, and in a sense they are. Of course, no doctor is going to adjust your medicine regime at 10pm at night, and virtually no ER will help you chronic pain during a severe flare.

       

      • (Score: 3, Insightful) by sjames on Saturday March 01 2014, @07:57AM

        by sjames (2882) on Saturday March 01 2014, @07:57AM (#9014) Journal

        It also happens quite deliberately where a patient knows very well that death is a distinct possibility but do it anyway.

        Some severe pain blots out thought.It blots out all but the pain. The only solace is knowing during moments of lucidity that it will go away eventually (except when it won't). Other types leave you almost numb but disconnected from your other senses as well.

    • (Score: 2, Informative) by Khyber on Saturday March 01 2014, @12:30PM

      by Khyber (54) on Saturday March 01 2014, @12:30PM (#9076) Journal

      "I really think the people wanting doctors to be stingy with the opoids have never felt real pain."

      I've been crushed by a truck, so I can say that I know what real pain is like. Doctors still need to be stingy with the opiates.

      --
      Destroying Semiconductors With Style Since 2008, and scaring you ill-educated fools since 2013.
      • (Score: 1) by sjames on Sunday March 02 2014, @08:38AM

        by sjames (2882) on Sunday March 02 2014, @08:38AM (#9452) Journal

        Imagine for a moment the very worst pain you felt from that. Now imagine you would feel that all day, every day for the rest of your life and the doctor suggests tylenol.

        Personally, I prefer to avoid strong painkillers. I do not suffer chronic pain, so I can do exactly that. It makes sense for doctors to be cautious in cases of acute pain (oddly enough, that's where they tend to be the most liberal). It makes no sense for chronic pain.

    • (Score: 0) by Anonymous Coward on Wednesday April 09 2014, @05:18AM

      by Anonymous Coward on Wednesday April 09 2014, @05:18AM (#28619)

      BYhtpc http://www.qs3pe5zgdxc9iovktapt2dbyppkmkqfz.com/ [qs3pe5zgdx...kmkqfz.com]