The newly approved pure hydrocodone product, Zohydro ER (extended release), will be made by the same company that manufactures Vivitrol, a drug used to treat patients addicted to opioids or alcohol, The New York Times reports.
The Food and Drug Administration (FDA) approved Zohydro ER last month for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro is expected to reach the market in early 2014.
In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.
In 2010, Zogenix bought the right to market Zohydro in the United States from another company, Elan, the article notes. The following year, a company named Alkermes, which makes Vivitrol, bought a unit of Elan that included Zohydro. The deal included the existing agreement with Zogenix.
Alkermes provides financial support to the American Society of Addiction Medicine, a leading professional group representing substance abuse experts, according to the newspaper. Dr. Stuart Gitlow, president of the group, told The New York Times he had been unaware of Alkermes’s involvement with Zohydro, adding the group would ask for more information from the company and then decide what, if anything, it will do about the situation.
Some law enforcement agencies and addiction experts have voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses.