Pharma naysayers have been known to accuse the industry of making drugs that cause side effects--and then making more drugs to treat those side effects. Now, a group of critics is taking aim at Zohydro, the new painkiller approved by FDA last month. Already worried that the powerful drug will spawn a new group of painkiller addicts, doctors point to the fact that the company that will manufacture Zohydro also sells Vivitrol, a medication designed to treat those very addicts.
As The New York Times reports, the U.S.-based drugmaker Alkermes ($ALKS) bought an Elan ($ELN) unit in 2011, and Zohydro came along with it. Alkermes also inherited a deal with Zogenix ($ZGNX), which had signed up to market the painkiller in the U.S. It was Zogenix that nabbed the FDA's approval to launch the new product in late October.
A panel of expert advisers voted against Zohydro's approval, saying that the drug's lack of abuse-deterrent features could pose a problem. Plus, as a pure hydrocodone formula--without the usual companion drug acetaminophen--Zohydro would be particularly attractive to addicts.
But the FDA chose to approve it anyway. At the time, Zogenix said it would monitor the drug's sales for signs that it was being abused and work to short-circuit any problems, the NYT notes. Immediately after, the company said it had signed up a partner to help develop an abuse-deterrent version of the drug.
Meanwhile, however, addiction specialists were raising their eyebrows, not only about the fact that Alkermes will be making Zohydro, but about the company's monetary support for the American Society of Addiction Medicine, a group that has been criticized for its financial ties to the pharma business.
The group tells the NYT that it will ask Alkermes for more information about its Zohydro business. And Alkermes tells the newspaper that it's "evaluating its role with respect to Zohydro" now that the drug is approved. Last November, Alkermes agreed to be Zogenix's exclusive manufacturer and supplier for the drug.
- read the NYT story (sub. req.)