A potent little painkiller is causing a big stir.
A coalition of more than 40 health care, consumer and addiction treatment groups is urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.
-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.
"It's a whopping dose of hydrocodone packed in an easy-to-crush
capsule," said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. "It will kill people as soon as it's released."
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.
"This could be the next OxyContin," says a petition on Change.org asking the FDA to reconsider.
"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."
Both Zohydro's maker, Zogenix, and the FDA assert the drug's benefits outweigh its risks.
Galer said the company will focus its commercial efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.
Bigger, stronger opioids -- especially those containing hydrocodone -- are a concern. Hydrocodone (Zohydro's sole ingredient) is one of the most frequently prescribed -- and abused -- opioids.
For that reason, in October, the FDA said it intended to shift hydrocodone-containing drugs from Schedule III to Schedule II. That rescheduling (still pending approval by the Drug Enforcement Administration) would mean much stricter dispensing and prescribing rules for hydrocodone-containing products.
Zohydro will enter the market already classified as a Schedule II -- one reason both the FDA and the drug's maker are confident it will not contribute to the broader overdose problem.
Zohydro's labeling will feature warnings about abuse, addiction and misuse, and Galer said Zogenix is working on an abuse-deterrent version of Zohydro that should become available in three years.