We submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on May 1, 2012 for Zohydro ER™ (hydrocodone bitartrate extended-release capsules) for the treatment of patients with moderate to severe chronic pain who require around-the-clock opioid therapy. Chronic pain is ongoing or recurrent pain that adversely affects an individual's well being.1 An estimated 116 million people in the United States are burdened with chronic pain, at a national economic cost of $560 to $635 billion annually.2
Zohydro ER is an oral, single-entity (without acetaminophen) novel, extended-release formulation of various strengths of hydrocodone dosed every 12 hours for around-the-clock management of moderate-to-severe chronic pain.
If approved, Zohydro ER could be the first hydrocodone product to offer the benefit of less frequent dosing and the ability to treat chronic pain patients without the risk of liver injury associated with the use of acetaminophen in high dosages or over long periods of time.
Currently, hydrocodone is only available in immediate-release, combination products, most commonly with the analgesic acetaminophen, and requires dosing every 4 to 6 hours. There is an established need for a single-entity (non-acetaminophen) hydrocodone medicine to provide people suffering from moderate-to-severe chronic pain with an effective option to manage their pain without the significant risk of liver injury associated with the use of acetaminophen in high dosages or over long periods of time.3 Research has shown that approximately 30-35% of hydrocodone combination products are taken on a chronic basis, for which there is ample evidence that this presents a health risk.
The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study (Study 801), and an open-label Phase 3 safety study (Study 802) of Zohydro ER. Study 801 successfully met its primary efficacy endpoint, demonstrating that Zohydro ER resulted in significantly (p=0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints in this study - the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication - were also met. Additional study endpoints were supportive of the efficacy of Zohydro ER compared to placebo. Overall, the most commonly reported adverse events (≥2%) in the placebo-controlled pivotal Phase 3 efficacy Study 801 in opioid-experienced patients were consistent with those typically seen with chronic opioid therapy and were constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting and pruritus. Study 802, in which patients received Zohydro ER for up to 12 months, further investigated Zohydro ER's tolerability and safety profile and showed that the incidence of adverse events was consistent with that seen in the pivotal Phase 3 efficacy study.
Zohydro ER uses Alkermes Pharma Ireland Ltd's patented Spheroidal Oral Drug Absorption System (SODAS®) drug delivery technology which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.
Zogenix is committed to responsible pain management and supporting appropriate use of pain treatments in people suffering from chronic pain.
Zohydro ER, classified as a Drug Enforcement Agency (DEA) Schedule II drug product, will carry strict prescription and dispensing rules. In addition, Zogenix has submitted in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products.
Our Zohydro ER sales force will receive training to recognize signs of inappropriate prescribing and will not interact with physicians engaging in this behavior. Zogenix is also examining a number of other measures to promote appropriate use and to help reduce diversion of the product.
Zohydro ER™ is a trademark of Zogenix, Inc.
SODAS® is a trademark of Alkermes Pharma Ireland Limited