News Feature | March 7, 2014

Experts Petition The FDA To Block Zogenix's Zohydro Painkiller

Source: Outsourced Pharma

By Cyndi Root

A group of experts have petitioned the Food and Drug Administration to block distribution of Zohydro, a painkiller. Manufactured by Zogenix, Inc., Zohydro is scheduled for distribution shortly. The coalition of doctors and addiction experts includes 42 people and the Public Citizen group. Law enforcement officials from 28 states have also asked the FDA to reconsider its position. In the petition, the expert group states, "Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child.”

Prescription Drug Abuse

The group of experts and law enforcement officials are aware of the prescription drug abuse epidemic in the U.S. Opioid pain medications like morphine, codeine, oxycodone, and hydrocodone are particularly troubling. In a 2012 survey, five million people, some as young as 12 years old, abused opioids, stimulants, and sedatives.

FDA Actions

In September 2013, the FDA initiated a program to deter opioid abuse. In a press release, the FDA outlined the changes including labeling changes and new postmarket study requirements. FDA Commissioner Margaret A. Hamburg, M.D said, “The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities.”

Zohydro Approval

The approval of Zohydro was made last year amidst the controversy about opioid abuse. FDA outside advisors registered concern about Zohydro during the approval process, worried about the drug’s potential to be crushed and injected. Zohydro is 10 times more potent than similar drugs like Vicodin or Lortab. In defense of its approval, the FDA said risks were minimal compared to the drug’s benefit.   

Phase 3 Study

Zogenix issued a press release recently announcing the publication of the results in a Phase 3 trial of Zohydro that led to the drug’s FDA approval. The study was published in the Pain Medicine journal, a publication of the American Academy of Pain Medicine (AAPM). Zohydro (hydrocodone bitartrate) extended-release capsules were well tolerated for low back pain and effective in relieving pain. 1,100 patients helped prove that Zohydro significantly improved pain relief compared to a placebo including a 30% improvement in pain intensity.