Zohydro, the Next OxyContin?
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 Pipedotters 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?
On the other hand, drug enforcement laws enacted in the face of this abuse sometimes interfere with the legitimate treatment of chronic pain. There's a shortage of pain management specialists as they have to put up with more paperwork outside scrutiny and hassle since they have to prescribe such large amounts of opiates. A lot of young MDs make the decision to go into other areas due to that.
These are powerful drugs that should be available in the cases they are needed without causing difficulty for either the physicians or the patients who need them.