Experts Voice Concern Over FDA Approval of New Hydrocodone Drug

The Food and Drug Administration’s (FDA) approval of the first pure hydrocodone drug in the United States concerns law enforcement agencies and addiction experts, who predict overdose deaths will increase, Newsday reports.

The drug, Zohydro ER (extended release), was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro is expected to reach the market in early 2014.

In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.

Zohydro is potentially 10 times stronger when abused than hydrocodone combination products, according to the article. Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. The opioid drug OxyContin has been reformulated to make it harder to crush or dissolve, but Zohydro does not include similar tamper-resistant features, the newspaper notes.

Zogenix has started the development of an abuse deterrent formulation of Zohydro , according to a company statement.

“That the FDA has approved another incredibly powerful painkiller without [tamper-proof features] is both disconcerting and dangerous,” said Jeffrey Reynolds, Executive Director of the Long Island Council on Alcoholism and Drug Dependence, who told the FDA expert panel he opposed Zohydro’s approval without safety features. “While this drug might be a godsend for people with acute pain, it’s a potential nightmare for those struggling with or at risk for addiction.”