FDA approves extended-release, single-entity hydrocodone product

FDA has approved hydrocodone bitartrate extended-release capsules (Zohydro ER, Zogenix) 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) and extended-release hydrocodone product. The labeling for Zohydro ER, an extended-release/long-acting (ER/LA) opioid analgesic, complies with updated labeling requirements for all ER/LA opioid analgesics announced by FDA on September 10, 2013. Zohydro ER is the first opioid to be labeled this way.

The new class of labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications. These warnings are expected to improve the safety of all such drugs by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices.

“The approval of Zohydro ER can be viewed as a breakthrough in pain management for those patients who may not achieve success with the current therapeutic options on the market or who are unable to tolerate these agents,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “It is important that careful and ongoing monitoring be performed while patients are on Zohydro ER, given the potential risk of overdose, so a thorough risk vs. benefit assessment should be made prior to initiation and during the course of therapy.”

Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids. Due to the risk 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 or not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.

Schedule II drugs can be dispensed only through a physician’s written prescription and no refills are allowed. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances. 

FDA is 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, defined as beyond 12 weeks. These studies also will be required for other ER/LA opioid analgesics.

The safety of Zohydro ER is based on clinical studies of more than 1,100 people living with chronic pain. Efficacy of Zohydro ER is based on a clinical study that enrolled more than 500 patients with chronic low back pain and showed significant improvement in chronic pain compared to placebo.

Zohydro ER will be part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). Originally approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to healthcare professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.

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