Controversy Surrounds FDA Approval of New Opioid Analgesic

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.

Comments (3)

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  1. Christine Wackowski says:

    I am unclear why the FDA would go AGAINST a panel of experts recommending rejection of this drug. I have been a health provider for many years and have not seen any significant value related to recent recommendations that have been approved by the FDA. With the vast drug abuse present in our country and the recent deaths in Pennsylvania due to combining heroin and fentanyl, why would an angency want to give more power to drug dealers?

  2. Bruce Parker MD FACEP says:

    This drug formulation could not be more similar to OxyContin, except that the active ingredient is hydrocodone. Is hydrocodone more/less likely to be abused? Chronic pain literature suggests that if we prescribe round the clock opiates, that most of the medication should be long acting forms. If marketed, this will be abused. Will it increase abuse? I remain unconvinced: a substantial part of the population experiences better pain relief with hydrocodone and less euphoria than oxycodone. I do not expect this to arrive on the VA formulary soon.

  3. Luz Castanon MD says:

    The reality is: why to produce a newer narcotic, if we still have problems with the ones already in the market?

    The reality is: they are more addicts patients than the ones that really need narcotics for severe pain!

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