FDA advisory gives thumbs down for Zogenix' Zohydro for chronic pain; EU label extension for Genzyme's Thyrogen

Shares of USA-based Zogenix (Nasdaq: ZGNX) plummeted 33.5% to $1.57 in after-hours trading on Friday (the shares were suspended during the day while an US Food and Drug Administration advisory panel reviewed the company New Drug Application), which resulted in a negative opinion.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted two to 11, with one abstention, against the approval of the company’s Zohydro ER (hydrocodone bitartrate extended-release capsules), a formulation of hydrocodone without acetaminophen, 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.

"Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue," said Stephen Farr, president and chief operating officer of Zogenix, adding: "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."