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.
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