November 6, 2013
New Opioid Analgesic Not Tamper-Resistant;
Approval Controversial

Washington, D.C.In a controversial action, the FDA has approved a new opioid analgesic even though it currently does not have tamper-resistant features.

In approving Zohydro ER (hydrocodone bitartrate extended-release capsules), the FDA went against an 11 to 2 recommendation by a panel of outside experts to reject the application from San Diego-based Zogenix, Inc. The new opioid analgesic is approved only for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved, single-entity extended-release hydrocodone product, as opposed to opioids combined with acetaminophen.

The FDA pointed out that Zohydro ER “will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”

Despite that, some nonprofit advocacy groups expressed concerns during the consideration process.

In a letter to the FDA, Steve Pasierb, chief executive officer of the Partnership at, urged that Zohydro ER not be approved for marketing without the requirement that it include tamper-resistant features.

“If all extended-release opiate products were required to incorporate tamper-resistant technology, we believe that we would start seeing a beneficial societal impact of less abuse of opioid products, fewer prescription drug overdoses, and fewer deaths,” Pasierb wrote. “As a public policy matter, we should all be encouraging companies to ‘retrofit’ their current products so that they are more difficult to abuse. And we certainly should not be approving any new opiates without these protections.”

In announcing the approval, the FDA emphasized that Zohydro ER “should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.”

The drug is the first to conform to updated labeling requirements for all extended release or long-acting (ER/LA) opioid analgesics announced in September. “These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices,” according to the FDA.

As with other ER/LA formulations, the FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with long-term use beyond 12 weeks.

Clinical studies of more than 1,100 people living with chronic pain were used to determine the safety of Zohydro ER, while the drug’s efficacy is based on a study of more than 500 patients who demonstrated significant improvement in chronic pain compared to placebo.

As is standard practice with makers of ER/LA opioid analgesics, the drug’s manufacturer is being required to make educational programs available to healthcare professionals on safe prescribing and also to provide medication guides and patient counseling documents containing information on the safe use, storage, and disposal of the product.

The most common side effects of Zohydro ER are constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.

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