FDA Approves Zohydro ER for Chronic Pain

by Karen Lee Richards Patient Advocate

Last week the U.S. Food and Drug Administration approved Zohydro ER (hydrocodone bitartrate extended-release capsules) 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 is the first single-entity form of hydrocodone to receive FDA approval. All other forms of hydrocodone on the U.S. market are combined with another weaker pain reliever like acetaminophen, ibuprofen or aspirin. Zohydro ER is also the first extended-release version of hydrocodone available in the U.S.

The announcement of Zohydro ER's approval was a surprise to many. In December 2012, the FDA's advisory panel overwhelmingly voted against recommending approval of the new drug. While the FDA is not required to follow the panel's recommendations, it usually does. Given the increased restrictions being placed on opioid prescribing, it was thought that they would probably go along with the panel's decision.

It should be noted, however, that Zohydro ER was approved as a Schedule II drug. That means it can only be dispensed through a physician's written prescription (it can't be called in) and no refills are allowed, which means you'll need a new hand-written prescription every month. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances.

Currently, other hydrocodone products (like Lortab and Vicodin) are classified as Schedule III drugs, which have fewer restrictions, but the FDA is considering reclassifying all hydrocodone medications to Schedule II. Zohydro ER was most likely put in the Schedule II classification because it is extended-release and therefore is more apt to be abused.

Zohydro ER will be available in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg strengths.

Important Information on How to Take Zohydro ER:* The capsules must be swallowed whole and must not be chewed, crushed, or dissolved. Taking chewed, crushed or dissolved Zohydro ER capsules or contents can lead to rapid release and absorption of a potentially fatal dose of hydrocodone.

  • Use Zohydro ER exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression).

  • Contact prescriber if pain control is not adequate or if there are adverse reactions occurring during therapy.

  • Do not discontinue Zohydro ER without first discussing the need for a tapering regimen with the prescriber.

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

Zohydro ER, manufactured by Zogenix, Inc., is the first drug to have the updated labeling now required by the FDA for all extended-release opioid analgesics. The FDA is also requiring postmarketing studies of Zohydro ER to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. These studies will also be required for other extended-release opioid analgesics.

For more information about Zohydro ER including the boxed warning and contraindications, you can download the Zohydro ER full prescribing information.


FDA News Release. FDA approves extended-release, single-entity hydrocodone product. October 25, 2013.


Karen Lee Richards
Meet Our Writer
Karen Lee Richards

Karen is the co-founder of the National Fibromyalgia Association. She writes for HealthCentral as a patient expert for Pain Management.