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news.Zogenix has announced the publication of results from the Phase III clinical study of Zohydro ER (hydrocodone bitartrate) extended-release capsules, which were originally reported in 2011 and were used as the basis for the Zohydro ER new drug application (NDA), which was approved by the US Food and Drug Administration (FDA) in October 2013.
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The results of Study 801 from the Phase III clinical study demonstrate that extended-release hydrocodone was well tolerated and effective for the treatment of moderate-to-severe chronic low back pain and was published online in the February issue of the peer-reviewed journal Pain Medicine. Pain Medicine is the official publication of the American Academy of Pain Medicine (AAPM).
The study is titled ‘Single-Entity Hydrocodone Extended-Release Capsules in Opioid-Tolerant Subjects With Moderate-to-Severe Chronic Low Back Pain: A Randomized Double-Blind, Placebo-Controlled Study’. It is currently available to subscribers on the journal’s website, and will be published in print at a later date.
Zogenix executive vice president and chief medical officer Dr Bradley Galer noted as the first and only extended-release hydrocodone without acetaminophen, the company expects Zohydro ER to fill a critical need for people suffering from chronic pain who are currently experiencing pain relief with around-the-clock immediate-release hydrocodone-acetaminophen combination products but are at risk for liver toxicity.
"Acetaminophen overdose is a leading cause of acute liver failure in the United States with almost two-thirds of those cases related to the use of these products. In addition, the comprehensive suite of appropriate use initiatives for Zohydro ER that Zogenix has initiated, which augment the Risk Evaluation Mitigation Strategies (REMS) for Extended-Release/Long Acting (ER/LA) Opioids required by the FDA, is designed to support the proper prescribing and use of our product," Dr Galer added.
Overall, Zohydro ER was studied in over 1,100 patients with moderate to severe chronic pain who participated in Study 801, the pivotal Phase III efficacy study and Study 802, an open-label Phase III long-term safety study.
The 801 efficacy study in subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved pain relief compared to placebo. The key secondary endpoints were also achieved: a significantly higher number of subjects experienced at least 30% improvement in pain intensity from screening to end of study (67.5%, Zohydro ER versus 31.1%, placebo).
The safety profile of Zohydro ER in both Phase 3 studies was generally well tolerated and the adverse reactions in = 2% of patients in placebo-controlled trials include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, edema peripheral, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain and tremor. Zohydro ER will be available in six dosage strengths ranging from 10mg to 50mg with dosing every 12 hours.
Zohydro ER uses Alkermes Pharma Ireland Limited’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.