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Controversy Surrounds FDA Approval of New Opioid Analgesic

by U.S. Medicine

February 5, 2014

SAN DIEGO — The Food and Drug Administration has approved a new opioid analgesic but not without controversy.

In approving Zohydro ER (hydrocodone bitartrate extended-release capsules), the FDA went against an 11-2 recommendation by a panel of outside experts to reject the application from San Diego-based Zogenix Inc. Concerns have centered around the product’s lack of tamper-resistant features.

Late last year, attorneys general from 28 states asked the FDA reconsider its approval of Zohydro, warning that the drug could start an epidemic of abuse.

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 and extended-release hydrocodone product, as opposed to opioids combined with acetaminophen. The drug also is the first to conform to updated labeling requirements for all extended-release or long-acting (ER/LA) opioid analgesics announced in September.

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.”

As with other ER/LA formulations, the FDA is requiring post-marketing 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.

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


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