FDA Agrees to Review Zohydro ER (Hydrocodone Bitartrate) for Chronic Pain
The FDA has assigned a target action date of March 1, 2013.
Zohydro ER is an oral, single-entity (without acetaminophen), extended-release formulation of various strengths of hydrocodone designed for administration every 12 hours for continuous management of moderate to severe chronic pain for an extended period. If approved, Zohydro ER may be the first hydrocodone product to offer less frequent dosing and the ability to treat patients with chronic pain without the risk of acetaminophen-related liver injury. Hydrocodone is currently available only in immediate-release combination products, most commonly combined with acetaminophen, and requires dosing every 4 to 6 hours.
Chronic pain is defined as ongoing or recurrent pain that adversely affects an individual's well-being. About 116 million people in the U.S. experience chronic pain, for an estimated national cost of $560 billion to $635 billion annually.
The NDA submission of Zohydro ER was based on data from more than 1,100 patients with chronic pain who participated in a pivotal phase III efficacy study (Study 801) and in an open-label phase III safety study (Study 802).
In Study 801, Zohydro ER significantly (P = 0.008) improved chronic pain relief compared with placebo. Two key secondary endpoints––the proportion of patients with at least 30% improvement in pain intensity and improvement of overall satisfaction with the medication––were also met. The most commonly reported adverse events were consistent with those typically seen with chronic opioid therapy and included constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus. In Study 802, patients received Zohydro ER for up to 12 months. The incidence of adverse events was consistent with that seen in the pivotal phase III efficacy study.
For the full news release visit the Zogenix Web site.