FDA Advisors Vote Against New Hydrocodone Painkiller

An FDA advisory committee recommended last week that the U.S. drug regulatory agency not approve a new hydrocodone-based narcotic drug for pain relief, indicating it could be heavily abused.  

The Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met on Friday, following a complete review of Zohydro ER.

The committee, which advises the FDA on the approval and use of painkillers, voted 11-2 against approval of the drug after a randomized controlled clinical trial revealed a much higher level of abuse with Zohydro than other opioid drugs, which likely weighed heavily in the panel’s decision.

Zohydro ER is a hydrocodone based opioid pain reliever (OPR) that was developed for treatment of moderate to severe chronic pain. Zohydro is classified as single-entity semisynthetic opioid analgesic.

Combination opioid pain killers usually contain another non-opioid medication, such as acetaminophen. Because acetaminophen overdose can potentially cause liver damage, drug companies created single-entity narcotic pain killers that do not contain Tylenol or other types of pain killers in combination.

While the committee believed the manufacturer, Zogenix Inc., met the regulatory guidelines for safety and efficacy regarding the drug, panelists felt the drug will become highly abused following its approval.

Hydrocodone is already the most widely abused prescription narcotic pain killer, linking Zohydro to a growing epidemic of abuse and highlighting the increasing rate of painkiller overdoses. Clinical trial findings of Zohydro included five deaths and positively linked one death as a result of overdose of hydrocodone to the drug.

The crushable pill form of Zohydro allows abusers to create a powder that is easily and readily available to snort, increasing its likelihood of abuse. Reviewers believe it will be more widely abused than what is normally seen with combination OPR drugs based on the abuse rate of oxycodone, commonly sold in generic form and under brand names such as OxyContin and Palladone.

The advisory committee’s vote against Zohydro approval may urge the FDA against approval of the drug in the U.S. While the FDA is not required to follow the committee’s lead or recommendation, the agency often does. Zogenix shares began dropping dramatically following the vote Friday.