FDA advisory committee votes against recommending approval for the first single-entity extended-release hydrocodone product.
As we reported earlier, the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met December 7, 2012, to review the New Drug Application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules), a hydrocodone-only opioid product developed by Zogenix, Inc.
The committee voted 11-2 against recommending approval of Zohydro, with several committee members expressing concerns over the potential for abuse, misuse, and diversion of a single-entity extended-release hydrocodone product.
Reuters reported that although Zohydro “had met narrow FDA targets for safety and efficacy,” committee members expressed concern that a pure hydrocodone product “could become a drug of choice for people addicted to other opioid painkillers including those based on the drug oxycodone.”
According to Reuters, Bob Rappaport, MD, director of the FDA division of anesthesia, analgesia and addiction products, said regulators must decide whether the panel's decision was based on a “tangible difference between Zohydro and opioid-based medications already available in the marketplace.”
If that is not the case, Rappaport told the committee, “You're punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that's not really something we can do.”
In a news release commenting on the FDA committee’s decision, Zogenix president and chief operating office Stephen Farr, PhD, said “Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue. However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”
Earlier, the committee had voted 5-9 against finding that Zohydro was safe for treating patients with moderate to severe chronic pain, and voted 7-6 in favor of finding Zohydro to be effective in treating pain.
The FDA has until March 1 to decide whether to approve Zohydro for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.