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FDA Okays Long-Acting Painkiller, Zohydro ER

First to have updated labeling now required for all ER/LA opioid analgesics (October 25)

The FDA has approved Zohydro ER (hydrocodone bitartrate extended-release capsules, Zogenix, Inc.) 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 (not combined with an analgesic, such as acetaminophen), extended-release hydrocodone product.

The drug is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, 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 approved labeling for Zohydro ER conforms to updated labeling requirements for all ER/LA opioid analgesics announced by the FDA on September 10, 2013. Zohydro ER is the first opioid to be labeled in this manner.

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. These studies will also be required for other ER/LA opioid analgesics.

Source: FDA; October 25, 2013.

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