Zogenix shares leap after FDA approval for Zohydro ER

Shares of USA-based Zogenix (Nasdaq: ZGNX) rocketed on Friday after the US Food and Drug Administration approved Zohydro ER (hydrocodone bitartrate) extended-release capsules for pain management. Shares rose as much as 53% hitting a high of $3.45 before closing at $3.04 on Friday, despite the decision being criticized by trade bodies.

Last year, 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.

Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The company outlined the benefit of the drug by stating that use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury. Acetaminophen overdose is a leading cause of acute liver failure in the USA, with 63% of unintentional acetaminophen overdoses attributed to the use of hydrocodone-acetaminophen combination products.