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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?"
(Score: 5, Informative) by mrbluze on Friday February 28 2014, @11:38PM
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, @12:54AM
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, @01:09AM
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, @01:09AM
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, @01:23AM
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, @01:55AM
Man, I hate going chunky-style. It always gives me the weirdest dreams.
(Score: 2) by mrbluze on Saturday March 01 2014, @02:55AM
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, @09:41AM
(Score: 1) by xtronics on Saturday March 01 2014, @02:48PM
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, @04:44PM
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, @02:56PM
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, @03:36PM
Also - having more choices and suppliers would lower the cost not raise it (remember when we had one choice for long distance? )