FDA approves Zohydro, first hydrocodone-only painkiller

It’s been a long ride for Zohydro ER and its California-based pharmaceutical firm Zogenix, but the journey is nearing an end.

Zohydro ER will be the first extended-release, hydrocodone-only painkiller to reach the market, expected in approximately four months.

On October 25, the FDA officially approved this highly controversial drug to treat severe chronic pain that is unresponsive to alternative therapies.

The approval came as a surprise since the FDA’s own panel of advisors voted strongly against recommending approval due to Zohydro’s potential for addiction and lack of tamper-resistant technology in December 2012, followed by an unspecified delay in March of this year.

Until now, hydrocodone was only sold in combination with non-addictive analgesics such as aspirin or acetaminophen (as in Vicodin), and the approval drew criticism from safety advocates who wanted anti-abuse design features that would make it harder for users to crush the pills and snort or inject them.

Vicodin contains up to 10 milligrams of hydrocodone, with a daily maximum dosage of around 60 milligrams. Zohydro ER, which would likely be taken twice a day, could result in a daily dosage of up to 100 milligrams.

To balance the needs of patients with chronic pain against the risk of misuse, Zohydro will be classified as a Schedule II controlled substance, which places strict security measures on its prescription, dispensing and use.

To further address the concerns of potential addiction, the FDA is requiring post-marketing studies of Zohydro to assess the risk of abuse, addiction and overdose associated with long-term use beyond 12 weeks.