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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 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.