Zohydro ER Deemed Safe, Effective as Long-Term Chronic Pain Treatment

A late-stage trial of extended-release hydrocodone bitartrate (Zohydro ER) pointed to a generally safe and well-tolerated response among patients with chronic pain for up to 1 year, according to Zogenix, Inc.

The phase 3 study found Zohydro ER’s safety and tolerability profile comparable with other opioid analgesics, according to Zogenix. In addition, 55% of patients treated with Zohydro ER and dosed every 12 hours for up to 1 year saw improvement in pain scores, and patients also experienced improvements in depression, anxiety, and function.

The most common adverse side effects were constipation, back pain, nausea, and vomiting.

Zohydro ER aims to reduce the number of hydrocodone doses per day and to eliminate acetaminophen, which can negatively affect the liver when taken chronically and at high doses. The drug is an opioid agonist indicated for treating pain severe enough to necessitate around-the-clock, long-term opioid treatment for when alternative treatment options are not adequate.

"In addition to needing options for chronic pain patients who are at risk for acetaminophen toxicity, prescribers may need to switch opioids if their patient's current opioid treatment becomes inadequate either due to loss of pain relief or increasing side effects," said Bradley Galer, MD, chief medical officer of Zogenix, in a press release. "That's why it's so important that physicians and their patients living with severe chronic pain have access to a full range of treatment options."

Addiction, abuse, and misuse of the drug could lead to overdose or death, the manufacturer cautioned. Children especially could fatally overdose on the drug if accidentally ingested.